Cordarone
30/06/10
Generic Name: amiodarone (oral) (A mi OH da rone)
Brand Names: Cordarone, Pacerone
What is amiodarone?
Amiodarone is an antiarrhythmic medication that affects the rhythm of heartbeats.
Amiodarone is used to help keep the heart beating normally in people with life-threatening heart rhythm disorders of the ventricles (the lower chambers of the heart that allow blood to flow out of the heart). Amiodarone is used to treat ventricular tachycardia or ventricular fibrillation.
Amiodarone may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about amiodarone?
Amiodarone is for use only in life-threatening situations. This medication has the potential to cause side effects that could be fatal, and you will receive your first few doses in a hospital setting.
Do not use this medication if you are allergic to amiodarone or iodine, or if you have certain heart conditions such as “AV block,” or a history of slow heart beats. Do not use amiodarone without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.
To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your thyroid and liver function may also need to be tested, and you may need eye exams and chest x-rays. Do not miss any scheduled appointments.
You may continue to have side effects from amiodarone after you stop taking it. It could take up to several months for the medicine to completely clear from your body.
What should I discuss with my healthcare provider before taking amiodarone?
Amiodarone is for use only in life-threatening situations. This medication has the potential to cause side effects that could be fatal, and you will receive your first few doses in a hospital setting.
You may continue to have side effects from amiodarone after you stop taking it. It could take up to several months for the medicine to completely clear from your body.
Do not use this medication if you are allergic to amiodarone or iodine, or if you have:
-
certain serious heart conditions, especially “AV block” (unless you have a pacemaker); or
-
a history of slow heart beats that have caused you to faint.
If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before taking amiodarone, tell your doctor if you have:
-
asthma or another lung disorder;
- liver disease;
-
vision problems;
-
high or low blood pressure;
-
a thyroid disorder;
-
an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or
-
if you have a pacemaker or defibrillator implanted in your chest.
FDA pregnancy category D. Do not use amiodarone without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. Amiodarone can pass into breast milk and may harm a nursing baby. Do not use this medication while you are breast-feeding a baby.
How should I take amiodarone?
You will receive your first few doses of amiodarone in a hospital setting where your heart can be monitored in case the medication causes serious side effects.
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
Take this medicine with a full glass of water.
You may take amiodarone with or without food but take it the same way every time.
It is important to use amiodarone regularly to get the most benefit. Keep using this medication even if you feel fine or have no symptoms. Get your prescription refilled before you run out of medicine completely.
To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your thyroid and liver function may also need to be tested, and you may need eye exams and chest x-rays. Do not miss any scheduled visits to your doctor.
If you need to have any type of surgery (including laser eye surgery), tell the surgeon ahead of time that you are using amiodarone. You may need to stop using the medicine for a short time.
This medication can cause you to have unusual results with certain thyroid tests. Tell any doctor who treats you that you are using amiodarone.
Store amiodarone at room temperature away from heat, moisture, and light.
See also: Cordarone dosage in more detail
What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include weakness, slow heart rate, feeling light-headed, or fainting.
What should I avoid while taking amiodarone?
Amiodarone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Grapefruit and grapefruit juice may interact with amiodarone and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.
Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Amiodarone can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.
Amiodarone side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects, even if they occur up to several months after you stop using amiodarone:
-
a new or a worsening irregular heartbeat pattern;
-
fast, slow, or pounding heartbeats;
-
feeling like you might pass out;
-
wheezing, cough, chest pain, trouble breathing, coughing up blood;
-
blurred vision, vision loss, headache or pain behind your eyes, sometimes with vomiting;
-
feeling short of breath, even with mild exertion, swelling, rapid weight gain;
-
weight loss, thinning hair, feeling too hot or too cold, increased sweating, irregular menstrual periods, swelling in your neck (goiter);
-
numbness, burning, pain, or tingling in your hands or feet; or
-
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
-
feeling dizzy or tired;
-
nausea, vomiting, stomach pain, constipation, loss of appetite;
-
sleep problems (insomnia);
-
weakness, lack of coordination; or
-
warmth, tingling, or redness under your skin.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect amiodarone?
Many drugs can interact with amiodarone. Below is only a partial list. Tell your doctor if you are using:
-
cimetidine (Tagamet);
-
clopidogrel (Plavix);
-
cyclosporine (Gengraf, Neoral, Sandimmune);
-
dextromethorphan (an over-the-counter cough medicine);
-
diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);
-
digoxin (digitalis, Lanoxin, Lanoxicaps);
-
loratadine (Claritin Alavert);
-
St. John’s wort;
-
an antidepressant;
-
a blood thinner such as warfarin (Coumadin);
-
a diuretic (water pill);
-
insulin or diabetes medication you take by mouth;
-
narcotic pain medication;
-
medication to treat HIV or AIDS;
-
an antibiotic such as azithromycin (Zithromax), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), levofloxacin (Levaquin), rifampin (Rifadin, Rimactane, Rifater, Rifamate), telithromycin (Ketek), and others;
-
an antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);
-
a beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta, Ziac), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), and others;
-
cholesterol-lowering medicines such as cholestyramine (Prevalite, Questran), atorvastatin (Lipitor), simvastatin (Zocor), lovastatin (Mevacor), pravastatin (Pravachol), or fluvastatin (Lescol);
-
heart rhythm medication such as disopyramide (Norpace), quinidine (Quinaglute, Quinidex), or procainamide (Procan, Pronestyl);
-
heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac), nifedipine (Procardia, Adalat), verapamil (Calan, Covera, Isoptin, Verelan), and others; or
-
seizure medication such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), and others.
This list is not complete and there are many other medicines that can cause serious drug interactions with amiodarone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.
Where can I get more information?
- Your pharmacist can provide more information about amiodarone.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
- Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 5.03. Revision Date: 06/11/2009 11:03:03 AM.
Constulose
30/06/10
Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 0.1 g or less of fructose). Lactulose solution contains potassium sorbate as an inactive ingredient.
Lactulose is a colonic acidifier which promotes laxation.
The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. It has the following structural formula:

The molecular weight is 342.30. It is freely soluble in water.
Constulose – Clinical Pharmacology
Lactulose is poorly absorbed from the gastrointestinal tract and no enzyme capable of hydrolysis of this disaccharide is present in human gastrointestinal tissue. As a result, oral doses of lactulose reach the colon virtually unchanged. In the colon, lactulose is broken down primarily to lactic acid, and also to small amounts of formic and acetic acids, by the action of colonic bacteria, which results in an increase in osmotic pressure and slight acidification of the colonic contents. This in turn causes an increase in stool water content and softens the stool.
Since lactulose does not exert its effect until it reaches the colon, and since transit time through the colon may be slow, 24 to 48 hours may be required to produce the desired bowel movement.
Lactulose given orally to man and experimental animals resulted in only small amounts reaching the blood. Urinary excretion has been determined to be 3% or less and is essentially complete within 24 hours.
Indications and Usage for Constulose
For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.
Contraindications
Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.
Warnings
A theoretical hazard may exist for patients being treated with lactulose solution who may be required to undergo electrocautery procedures during proctoscopy or colonoscopy. Accumulation of H2 gas in significant concentration in the presence of an electrical spark may result in an explosive reaction. Although this complication has not been reported with lactulose, patients on lactulose therapy undergoing such procedures should have a thorough bowel cleansing with a non-fermentable solution. Insufflation of CO2 as an additional safeguard may be pursued but is considered to be a redundant measure.
Precautions
General
Since lactulose solution contains galactose (less than 1.6 g/15 mL) and lactose (less than 1.2 g/15 mL) it should be used with caution in diabetics.
Information for Patients
In the event that an unusual diarrheal condition occurs, contact your physician.
Laboratory Tests
Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically.
Drug Interactions
Results of preliminary studies in humans and rats suggest that non-absorbable antacids given concurrently with lactulose may inhibit the desired lactulose-induced drop in colonic pH. Therefore, a possible lack of desired effect of treatment should be taken into consideration before such drugs are given concomitantly with lactulose solution.
Carcinogenesis, Mutagenesis, Impairment of Fertility
There are no known human data on long-term potential for carcinogenicity, mutagenicity, or impairment of fertility.
There are no known animal data on long-term potential for mutagenicity.
Administration of lactulose solution in the diet of mice for 18 months in concentrations of 3 and 10 percent (v/w) did not produce any evidence of carcinogenicity.
In studies of mice, rats, and rabbits, doses of lactulose solution up to 6 or 12 mL/kg/day produced no deleterious effects in breeding, conception, or parturition.
Pregnancy
Pregnancy category B. Reproduction studies have been performed in mice, rats, and rabbits at doses up to 3 or 6 times the usual human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to lactulose. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lactulose solution is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Adverse Reactions
Precise frequency data are not available.
Initial dosing may produce flatulence and intestinal cramps, which are usually transient. Excessive dosage can lead to diarrhea with potential complications such as loss of fluids, hypokalemia, and hypernatremia.
Nausea and vomiting have been reported.
Overdosage
Signs And Symptoms:
There have been no reports of accidental overdosage. In the event of overdosage, it is expected that diarrhea and abdominal cramps would be the major symptoms. Medication should be terminated.
Oral LD50: The acute oral LD50 of the drug is 48.8 mL/kg in mice and greater than 30 mL/kg in rats.
Dialysis: Dialysis data are not available for lactulose. Its molecular similarity to sucrose, however, would suggest that it should be dialyzable.
Constulose Dosage and Administration
The usual dose is 1 to 2 tablespoonfuls (15 to 30 mL, containing 10 g to 20 g of lactulose) daily. The dose may be increased to 60 mL daily if necessary. Twenty-four to 48 hours may be required to produce a normal bowel movement.
Note: Some patients have found that lactulose solution may be more acceptable when mixed with fruit juice, water or milk.
How is Constulose Supplied
Lactulose Solution is a natural colored and an unflavored solution available in 8 fl oz (237 mL) and 1 quart (946 mL) bottles.
Lactulose Solution contains lactulose 667 mg/mL (10 g/15 mL).
Store between 36°-86°F (2°-30°C). Do not freeze.
Under recommended storage conditions, a normal darkening of color may occur. Such darkening is characteristic of sugar solutions and does not affect therapeutic action. Prolonged exposure to temperatures above 86°F (30°C) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable. If this condition develops, do not use.
Prolonged exposure to freezing temperatures may cause change to a semi-solid, too viscous to pour. Viscosity will return to normal upon warming to room temperature.
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.
Packaged and distributed by
Actavis MidAtlantic LLC
Baltimore, MD 21244 USA
Manufactured by
Inalco S.p.A.
20139 Milano, Italy
FORM NO. 1358
Rev. 1/06
VC2755
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Revised: 10/2008Actavis Mid Atlantic LLC
Contac 12 Hour
30/06/10
Generic Name: chlorpheniramine and phenylpropanolamine (klor feh NEER a meen and feh nill proe pa NO la meen)
Brand Names: A.R.M. Allergy Relief, Allerest 12 Hour, Chlornade, Condrin, Contac 12 Hour, Decongex-3, Demazin, Dura-Vent/A, Equi-Nade, Genamin, Gencold, Histade, Or-Phen-Ade, Ordrine, Ornade Spansules, Resaid, Rescon Liquid, Rhinolar-EX, Teldrin, Triac, Triaminic, Vanex Forte-R
What is Contac 12 Hour (chlorpheniramine and phenylpropanolamine)?
Chlorpheniramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Chlorpheniramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.
Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas and allows nasal passages to open up.
Chlorpheniramine and phenylpropanolamine is used to treat nasal congestion and sinusitis (inflammation of the sinuses) associated with allergies, hay fever, and the common cold.
Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.
Chlorpheniramine and phenylpropanolamine may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about Contac 12 Hour (chlorpheniramine and phenylpropanolamine)?
Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.
Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine and phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking chlorpheniramine and phenylpropanolamine.
Do not take more of this medication than is recommended. If your symptoms do not improve, or if they worsen, talk to your doctor.
Who should not take Contac 12 Hour (chlorpheniramine and phenylpropanolamine)?
Do not take chlorpheniramine and phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.
Before taking this medication, tell your doctor if you have
- kidney disease,
- liver disease,
-
diabetes,
-
glaucoma,
-
any type of heart disease or high blood pressure,
-
thyroid disease,
-
emphysema or chronic bronchitis, or
-
difficulty urinating or an enlarged prostate.
You may not be able to take chlorpheniramine and phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Chlorpheniramine and phenylpropanolamine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication passes into breast milk and may harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from chlorpheniramine and phenylpropanolamine. You may require a lower dose of this medication. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.
How should I take Contac 12 Hour (chlorpheniramine and phenylpropanolamine)?
Take chlorpheniramine and phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water. Do not crush, chew, or break the long-acting or sustained-release forms of this medication. Swallow them whole. If you are unsure of the formulation of your medicine, ask your pharmacist for help.
If you cannot swallow the tablets or capsules, look for a liquid form of the medication.
To ensure that you get a correct dose, measure the liquid forms of chlorpheniramine and phenylpropanolamine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.
Do not take more of this medication than is recommended. An overdose of this medication can cause serious harm.
Do not take chlorpheniramine and phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, talk to your doctor.
Store chlorpheniramine and phenylpropanolamine at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.
What happens if I overdose?
Seek emergency medical attention.
Symptoms of a chlorpheniramine and phenylpropanolamine overdose include a dry mouth, large pupils, flushing, nausea, and vomiting.
What should I avoid while taking Contac 12 Hour (chlorpheniramine and phenylpropanolamine)?
Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine and phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking chlorpheniramine and phenylpropanolamine.
Chlorpheniramine and phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if chlorpheniramine and phenylpropanolamine is taken with any of these medications.
Contac 12 Hour (chlorpheniramine and phenylpropanolamine) side effects
Serious side effects are unlikely to occur. Stop taking chlorpheniramine and phenylpropanolamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).
Other, less serious side effects may be more likely to occur. Continue to take chlorpheniramine and phenylpropanolamine and talk to your doctor or try another similar medication if you experience
-
dryness of the eyes, nose, and mouth;
-
drowsiness or dizziness;
-
blurred vision;
-
difficulty urinating; or
-
excitation in children.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect Contac 12 Hour (chlorpheniramine and phenylpropanolamine)?
Do not take chlorpheniramine and phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.
Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking chlorpheniramine and phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain chlorpheniramine, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.
Chlorpheniramine and phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if chlorpheniramine and phenylpropanolamine is taken with any of these medications.
Drugs other than those listed here may also interact with chlorpheniramine and phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.
Where can I get more information?
- Your pharmacist has additional information about chlorpheniramine and phenylpropanolamine written for health professionals that you may read.
What does my medication look like?
Many formulations of chlorpheniramine and phenylpropanolamine are available both over-the-counter and with a prescription. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
- Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 5.05. Revision Date: 4/26/06 4:12:59 PM.
Contac 12 Hour Allergy
30/06/10
Generic Name: clemastine (CLEM as teen)
Brand Names: Allerhist-1, Contac 12 Hour Allergy, Tavist, Tavist-1
What is Contac 12 Hour Allergy (clemastine)?
Clemastine is an antihistamine. Clemastine blocks the effects of the naturally occurring chemical histamine in your body.
Clemastine is used to treat sneezing, runny nose, itching watery eyes, hives, rashes, itching, and other symptoms of allergies and the common cold.
Clemastine is may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about Contac 12 Hour Allergy (clemastine)?
Use caution when driving, operating machinery, or performing other hazardous activities. Clemastine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking clemastine.
Who should not take Contac 12 Hour Allergy (clemastine)?
Do not take clemastine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.
Before taking this medication, tell your doctor if you have
-
glaucoma or increased pressure in the eye;
-
a stomach ulcer;
-
an enlarged prostate, bladder problems, or difficulty urinating;
-
an overactive thyroid (hyperthyroidism);
-
hypertension or any type of heart problems; or
-
asthma.
You may not be able to take clemastine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.
Clemastine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take clemastine without first talking to your doctor if you are pregnant. Clemastine passes into breast milk. Infants are especially sensitive to the effects of antihistamines, and serious side effects could occur in a nursing baby. Clemastine is not recommended if you are breast-feeding a baby. Do not take clemastine without first talking to your doctor if you are nursing a baby. If you are over 60 years of age, you may be more likely to experience side effects from clemastine. You may require a lower dose of this medication.
How should I take Contac 12 Hour Allergy (clemastine)?
Take clemastine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water.
Clemastine can be taken with or without food.
To ensure that you get a correct dose, measure the syrup form of clemastine with a special dose-measuring spoon or cup, not with a regular tablespoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.
Never take more of this medication than is prescribed for you. The maximum amount of clemastine that you should take in 1 day is 8.04 mg.
Store clemastine at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.
What happens if I overdose?
Seek emergency medical attention.
Symptoms of a clemastine overdose include extreme sleepiness, confusion, weakness, ringing in the ears, blurred vision, large pupils, dry mouth, flushing, fever, shaking, insomnia, hallucinations, and possibly seizures.
What should I avoid while taking Contac 12 Hour Allergy (clemastine)?
Use caution when driving, operating machinery, or performing other hazardous activities. Clemastine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking clemastine.
Contac 12 Hour Allergy (clemastine) side effects
Stop taking clemastine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).
Other, less serious side effects may be more likely to occur. Continue to take clemastine and talk to your doctor if you experience
-
sleepiness, fatigue, or dizziness;
-
headache;
-
dry mouth; or
-
difficulty urinating or an enlarged prostate.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Contac 12 Hour Allergy (clemastine)?
Do not take clemastine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.
Talk to your pharmacist before taking other over-the-counter cough, cold, allergy, or insomnia medications. These may contain medicines similar to clemastine, which could lead to an overdose of antihistamine.
Before taking this medication, tell your doctor if you are taking any of the following medicines:
-
anxiety or sleep medicines such as alprazolam (Xanax), diazepam (Valium), chlordiazepoxide (Librium), temazepam (Restoril), or triazolam (Halcion);
-
medications for depression such as amitriptyline (Elavil), doxepin (Sinequan), nortriptyline (Pamelor), fluoxetine (Prozac), sertraline (Zoloft), or paroxetine (Paxil); or
-
any other medications that make you feel drowsy, sleepy, or relaxed.
Drugs other than those listed here may also interact with clemastine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.
Where can I get more information?
- Your pharmacist has more information about clemastine written for health professionals that you may read.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed
- Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 4.04. Revision Date: 4/12/2009 4:38:13 PM.
Contac 12-Hour
30/06/10
Generic Name: pseudoephedrine (Oral route)
soo-doe-e-FED-rin
Commonly used brand name(s):
In the U.S.
- 12 Hour Cold Maximum Strength
- Biofed
- Cenafed
- Chlor-Trimeton Nasal Decongestant
- Contac 12-Hour
- Dimetapp Decongestant
- Efidac 24 Pseudoephedrine
- ElixSure Congestion Children’s
- Genaphed
- Pediacare Decongestant Infants
- Simply Stuffy
- Sudafed
Available Dosage Forms:
- Suspension
- Tablet
- Capsule, Extended Release
- Tablet, Chewable
- Tablet, Extended Release
- Solution
- Syrup
- Liquid
- Capsule
- Capsule, Liquid Filled
Therapeutic Class: Decongestant
Pharmacologic Class: Alpha-Adrenergic Agonist
Uses For Contac 12-Hour
Pseudoephedrine is used to relieve nasal or sinus congestion caused by the common cold, sinusitis, and hay fever and other respiratory allergies. It is also used to relieve ear congestion caused by ear inflammation or infection.
Some of these preparations are available only with your doctor’s prescription.
Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .
Before Using Contac 12-Hour
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Pseudoephedrine may be more likely to cause side effects in infants, especially newborn and premature infants, than in older children and adults.
Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .
Geriatric
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of pseudoephedrine in the elderly with use in other age groups.
Breast Feeding
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Interactions with Medicines
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Clorgyline
- Dihydroergotamine
- Furazolidone
- Iproniazid
- Isocarboxazid
- Linezolid
- Moclobemide
- Nialamide
- Pargyline
- Phenelzine
- Procarbazine
- Rasagiline
- Selegiline
- Toloxatone
- Tranylcypromine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Guanethidine
- Methyldopa
- Midodrine
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Type 2 diabetes mellitus—Use of pseudoephedrine may cause an increase in blood glucose levels
- Enlarged prostate or
- Glaucoma, or a predisposition to glaucoma or
- Heart disease or blood vessel disease or
- High blood pressure—Pseudoephedrine may make the condition worse
- Overactive thyroid—Use of pseudoephedrine may make the condition worse
Proper Use of pseudoephedrine
This section provides information on the proper use of a number of products that contain pseudoephedrine. It may not be specific to Contac 12-Hour. Please read with care.
For patients taking pseudoephedrine extended-release capsules:
- Swallow the capsule whole. However, if the capsule is too large to swallow, you may mix the contents of the capsule with jam or jelly and swallow without chewing.
- Do not crush or chew before swallowing.
For patients taking pseudoephedrine extended-release tablets:
- Swallow the tablet whole.
- Do not break, crush, or chew before swallowing.
To help prevent trouble in sleeping, take the last dose of pseudoephedrine for each day a few hours before bedtime. If you have any questions about this, check with your doctor.
Take this medicine only as directed. Do not take more of it, do not take it more often, and do not take it for a longer period of time than recommended on the label (usually 7 days), unless otherwise directed by your doctor. To do so may increase the chance of side effects.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For nasal or sinus congestion:
- For regular (short-acting) oral dosage form (capsules, oral solution, syrup, or tablets):
- Adults and children 12 years of age and older—60 milligrams (mg) every four to six hours. Do not take more than 240 mg in twenty-four hours.
- Children 6 to 12 years of age—30 mg every four to six hours. Do not take more than 120 mg in twenty-four hours.
- Children 4 to 6 years of age—15 mg every four to six hours. Do not take more than 60 mg in twenty-four hours.
- Children and infants up to 4 years of age—Use is not recommended .
- For long-acting oral dosage form (extended-release capsules or extended-release tablets):
- Adults and children 12 years of age and older—120 mg every 12 hours, or 240 mg every 24 hours. Do not take more than 240 mg in 24 hours.
- Infants and children up to 12 years of age—Use is not recommended .
- For regular (short-acting) oral dosage form (capsules, oral solution, syrup, or tablets):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Precautions While Using Contac 12-Hour
If symptoms do not improve within 7 days or if you also have a high fever, check with your doctor since these signs may mean that you have other medical problems.
Contac 12-Hour Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Rare – more common with high doses
- Convulsions (seizures)
- hallucinations (seeing, hearing, or feeling things that are not there)
- irregular or slow heartbeat
- shortness of breath or troubled breathing
Symptoms of overdose
- Convulsions (seizures)
- fast breathing
- hallucinations (seeing, hearing, or feeling things that are not there)
- increase in blood pressure
- irregular heartbeat (continuing)
- shortness of breath or troubled breathing (severe or continuing)
- slow or fast heartbeat (severe or continuing)
- unusual nervousness, restlessness, or excitement
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Nervousness
- restlessness
- trouble in sleeping
Less common
- Difficult or painful urination
- dizziness or light-headedness
- fast or pounding heartbeat
- headache
- increased sweating
- nausea or vomiting
- trembling
- unusual paleness
- weakness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
Contac Cold
30/06/10
Generic Name: pseudoephedrine (SOO doe ee FED rin)
Brand Names: Chlor Trimeton Nasal Decongestant, Contac Cold, Drixoral Decongestant Non-Drowsy, Elixsure Decongestant, Entex, Genaphed, Kid Kare Drops, nasofed, Seudotabs, Silfedrine, Sudafed, Sudafed 12-Hour, Sudafed 24-Hour, Sudafed Children’s Nasal Decongestant, Sudodrin, SudoGest, SudoGest 12 Hour, Suphedrin, Triaminic Softchews Allergy Congestion, Unifed
What is Contac Cold (pseudoephedrine)?
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
Pseudoephedrine is used to treat nasal and sinus congestion, or congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) tubes.
Pseudoephedrine may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about Contac Cold (pseudoephedrine)?
Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains pseudoephedrine. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.
What should I discuss with my healthcare provider before taking Contac Cold (pseudoephedrine)?
Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use this medication if you are allergic to pseudoephedrine or to other decongestants, diet pills, stimulants, or ADHD medications.
Ask a doctor or pharmacist if it is safe for you to take pseudoephedrine if you have:
-
heart disease or high blood pressure;
-
diabetes; or
-
a thyroid disorder.
FDA pregnancy category C. It is not known whether pseudoephedrine is harmful to an unborn baby. Before you take this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.
How should I take Contac Cold (pseudoephedrine)?
Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.
Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take this medicine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.
Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.
If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.
Store the medication at room temperature away from moisture and heat.
What happens if I miss a dose?
Since cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
Symptoms of a pseudoephedrine overdose may include feeling restless or nervous.
What should I avoid while taking Contac Cold (pseudoephedrine)?
Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.
Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. Pseudoephedrine is contained in many over-the-counter medications. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains pseudoephedrine.
Contac Cold (pseudoephedrine) side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:
-
fast, pounding, or uneven heartbeat;
-
severe dizziness, anxiety, restless feeling, or nervousness;
-
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
-
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).
Less serious side effects may include:
-
mild loss of appetite;
-
warmth, tingling, or redness under your skin;
-
feeling excited or restless;
-
sleep problems (insomnia); or
-
skin rash or itching.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Contac Cold (pseudoephedrine)?
Before taking this medication, tell your doctor if you are using any of the following drugs:
-
medicines to treat high blood pressure;
-
a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or
-
antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.
This list is not complete and there may be other drugs that can interact with pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Where can I get more information?
- Your pharmacist can provide more information about pseudoephedrine.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
- Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 5.09. Revision Date: 11/19/2009 8:57:03 AM.
Contac Cold and Flu Maximum Strength
30/06/10
Generic Name: acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine (a SEET a MIN oh fen, KLOR fen EER a meen, DEX troe meth OR fan, SOO doe ee FED rin)
Brand Names: Alka-Seltzer Plus Cough and Cold Liquigel, Comtrex Cold and Flu Maximum Strength Liquid, Contac Cold and Flu Maximum Strength, Robitussin Flu, Robitussin Honey Flu Nighttime, Theraflu (pseudoephedrine) Cold & Cough, Theraflu Flu & Cough, Theraflu Night Cough and Cold and Flu, Theraflu Nightime Maximum Strength, Theraflu Severe Cold & Congestion, Triaminic Cold and Fever, Tylenol Cold Complete Formula, Vicks 44 Cold, Flu and Cough, Vicks Formula 44M
What is acetaminophen, chlorpheniramine, dextromethorphan and pseudoephedrine?
Acetaminophen is a pain reliever and fever reducer.
Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Dextromethorphan is a cough suppressant. It affects the cough reflex in the brain that triggers coughing.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine is used to treat runny or stuffy nose, sinus congestion, cough, and pain or fever caused by the common cold or flu.
Acetaminophen, chlorpheniramine, dextromethorphan and pseudoephedrine may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about acetaminophen, chlorpheniramine, dextromethorphan and pseudoephedrine?
Do not take pseudoephedrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur. Do not take more of this medication than is recommended. An overdose of acetaminophen can cause damage to your liver. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Do not use any other cough, cold, or allergy medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen (sometimes abbreviated as “APAP”), chlorpheniramine, dextromethorphan, or pseudoephedrine. Do not give this medicine to a child without a doctor’s advice. Death can occur from the misuse of cough or cold medicine in very young children. Always ask your doctor before treating a cough or cold in a child.
What should I discuss with my healthcare provider before taking acetaminophen, chlorpheniramine, dextromethorphan and pseudoephedrine?
Do not use this medication if you are allergic to acetaminophen, chlorpheniramine, dextromethorphan or pseudoephedrine, or to similar medications such as other decongestants, diet pills, stimulants, or ADHD medications. Do not use this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take a cough or cold medicine before the MAO inhibitor has cleared from your body.
Ask a doctor or pharmacist about using acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine if you have:
-
liver or kidney disease;
-
alcoholism or cirrhosis of the liver;
-
heart disease or high blood pressure;
-
diabetes;
-
a thyroid disorder;
-
glaucoma; or
-
an enlarged prostate or problems with urination.
FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Artificially-sweetened liquid forms of cough-and-cold medications may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.
How should I take acetaminophen, chlorpheniramine, dextromethorphan and pseudoephedrine?
Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cough-and-cold medicines should be taken only for a short time until your symptoms clear up.
Drink extra fluids while you are taking acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine. An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. One packet of the oral powder may contain up to 1000 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.
Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.
If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.
Store the medicine at room temperature, away from heat, light, and moisture.
What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
Overdose symptoms may also include dry mouth, feeling restless or nervous, dizziness, drowsiness, diarrhea, loss of appetite, warmth or tingly feeling, seizure (convulsions), or coma.
What should I avoid while taking acetaminophen, chlorpheniramine, dextromethorphan and pseudoephedrine?
Do not use any other cough, cold, pain, or allergy medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”), chlorpheniramine, dextromethorphan and pseudoephedrine are contained in many combination medicines. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen, APAP, chlorpheniramine, dextromethorphan or pseudoephedrine. Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor’s advice, and never take more than 2 grams (2000 mg) of acetaminophen per day. This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Avoid becoming overheated or dehydrated during exercise and in hot weather.
Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with pseudoephedrine can increase your risk of unpleasant side effects.
Acetaminophen, chlorpheniramine, dextromethorphan and pseudoephedrine side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:
-
fast, pounding, or uneven heartbeat;
-
confusion, hallucinations, unusual thoughts or behavior;
-
slow, shallow breathing;
-
severe dizziness, anxiety, restless feeling, or nervousness;
-
urinating less than usual or not at all;
-
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;
-
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure); or
-
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
-
blurred vision, dry mouth;
-
nausea, stomach pain, constipation;
-
warmth, tingling, or redness under your skin;
-
restless or excitability (especially in children);
-
sleep problems (insomnia);
-
dizziness, drowsiness;
-
problems with memory or concentration;
-
ringing in your ears; or
-
skin rash, redness, or itching.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect acetaminophen, chlorpheniramine, dextromethorphan and pseudoephedrine?
Before taking this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine or dextromethorphan.
Also tell your doctor if you are using any of the following drugs:
-
celecoxib (Celebrex);
-
cinacalcet (Sensipar);
-
darifenacin (Enablex);
-
imatinib (Gleevec);
-
isoniazid;
-
quinidine (Quinaglute, Quinidex);
-
ranolazine (Ranexa)
-
ritonavir (Norvir);
-
sibutramine (Meridia);
-
terbinafine (Lamisil);
-
zidovudine (Retrovir, AZT);
-
an antidepressant;
-
a bronchodilator;
-
a diuretic (water pill);
-
medication to treat irritable bowel syndrome, bladder spasms, or urinary incontinence;
-
aspirin or salicylates (such as Disalcid, Doan’s Pills, Dolobid, Salflex, Tricosal, and others);
-
medicines to treat high blood pressure;
-
gout medication such as probenecid (Benemid);
-
a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or
-
seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).
This list is not complete and there may be other drugs that can interact with acetaminophen, chlorpheniramine, dextromethorphan and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Where can I get more information?
- Your pharmacist can provide more information about acetaminophen, chlorpheniramine, dextromethorphan and pseudoephedrine.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
- Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 6.03. Revision Date: 07/29/2009 10:29:24 AM.
Contac Day and Night Allergy
30/06/10
Generic Name: acetaminophen, diphenhydramine, and pseudoephedrine (a SEET a MIN oh fen, dye fen HYE dra meen, soo doe e FED rin)
Brand Names: Benadryl Cold, Contac Day and Night Allergy
What is Contac Day and Night Allergy (acetaminophen, diphenhydramine, and pseudoephedrine)?
Acetaminophen is a pain reliever and fever reducer.
Diphenhydramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of acetaminophen, diphenhydramine, and pseudoephedrine is used to treat runny or stuffy nose, sinus congestion, sneezing, and pain or fever caused by allergies or the common cold.
Acetaminophen, diphenhydramine, and pseudoephedrine may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about Contac Day and Night Allergy (acetaminophen, diphenhydramine, and pseudoephedrine)?
Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Do not use this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Do not take more of this medication than is recommended. An overdose of acetaminophen can cause damage to your liver. Do not use any other cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen (sometimes abbreviated as “APAP”), diphenhydramine, or pseudoephedrine. Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor’s advice, and never take more than 2 grams (2000 mg) per day.
What should I discuss with my healthcare provider before taking Contac Day and Night Allergy (acetaminophen, diphenhydramine, and pseudoephedrine)?
Do not use this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take a decongestant before the MAO inhibitor has cleared from your body. Do not take this medication if you are allergic to acetaminophen, diphenhydramine, or pseudoephedrine, or to other antihistamines or decongestants, diet pills, stimulants, or ADHD medications.
Ask a doctor or pharmacist about using acetaminophen, diphenhydramine, and pseudoephedrine if you have:
-
heart disease or high blood pressure;
-
liver disease, alcoholism, or cirrhosis of the liver;
-
glaucoma;
-
kidney disease;
-
diabetes;
-
a thyroid disorder;
-
an enlarged prostate; or
-
problems with urination.
This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.
How should I take Contac Day and Night Allergy (acetaminophen, diphenhydramine, and pseudoephedrine)?
Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine should be taken only for a short time until your symptoms clear up.
An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. One acetaminophen, diphenhydramine, and pseudoephedrine pill may contain up to 500 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Take this medication with food or milk if it upsets your stomach. Drink extra fluids while you are taking acetaminophen, diphenhydramine, and pseudoephedrine.
Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.
This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.
If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.
Store this medication at room temperature, away from heat, light, and moisture.
What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
Overdose symptoms may also include feeling restless or nervous, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).
What should I avoid while taking Contac Day and Night Allergy (acetaminophen, diphenhydramine, and pseudoephedrine)?
Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.
Do not use any other cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”), diphenhydramine, and pseudoephedrine are contained in many combination medicines. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen, APAP, diphenhydramine, or pseudoephedrine. Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor’s advice, and never take more than 2 grams (2000 mg) per day. This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Avoid becoming overheated or dehydrated during exercise and in hot weather.
Contac Day and Night Allergy (acetaminophen, diphenhydramine, and pseudoephedrine) side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:
-
fast, pounding, or uneven heartbeat;
-
confusion, hallucinations, unusual thoughts or behavior;
-
severe dizziness, anxiety, restless feeling, or nervousness;
-
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
-
urinating less than usual or not at all;
-
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
-
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
-
blurred vision;
-
dry mouth;
-
mild loss of appetite;
-
nausea, stomach pain, constipation;
-
dizziness, drowsiness;
-
problems with memory or concentration;
-
ringing in your ears;
-
restless or excitability (especially in children);
-
sleep problems (insomnia);
-
skin rash, redness, or itching; or
-
warmth, tingling, or redness under your skin.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Contac Day and Night Allergy (acetaminophen, diphenhydramine, and pseudoephedrine)?
Before taking this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by diphenhydramine.
Also tell your doctor if you are using any of the following drugs:
-
an antidepressant;
-
a bronchodilator;
-
a diuretic (water pill);
-
gout medications;
-
blood pressure medication;
-
medication to treat irritable bowel syndrome;
-
bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);
-
seizure medication;
-
isoniazid;
-
zidovudine (Retrovir, AZT);
-
aspirin or salicylates (such as Disalcid, Doan’s Pills, Dolobid, Salflex, Tricosal, and others); or
-
a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.
This list is not complete and there may be other drugs that can interact with acetaminophen, diphenhydramine, and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Where can I get more information?
- Your pharmacist can provide more information about acetaminophen, diphenhydramine, and pseudoephedrine.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
- Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 8.01. Revision Date: 07/29/2009 10:50:21 AM.
Generic Name: acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine (a seet a MIN oh fen/klor fen IR a meen/dex troe meth OR fan/fen ill proe pa NOLE a meen)
Brand Names: Comtrex Cold and Flu Maximum Strength, Comtrex Maximum Strength Cold Relief, Contac Severe Cold and Flu Maximum Stength
What is Contac Severe Cold and Flu Maximum Stength (acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine)?
Acetaminophen is a pain reliever and a fever reducer. It is used to treat many conditions, such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.
Chlorpheniramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Chlorpheniramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.
Dextromethorphan is a cough suppressant. It suppresses an area in the brain that causes coughing.
Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries) allowing nasal passages to open up.
Acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine is used to treat nasal congestion, sinusitis (inflammation of the sinuses), runny nose, watery eyes, headache, body aches, and coughs associated with allergies, hay fever, and the common cold.
Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.
Acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about Contac Severe Cold and Flu Maximum Stength (acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine)?
Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.
Use caution when driving, operating machinery, or performing other hazardous activities. Acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine. Alcohol may also cause damage to the liver when it is taken with acetaminophen.
Who should not take Contac Severe Cold and Flu Maximum Stength (acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine)?
Do not take this medication without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease. You may not be able to take acetaminophen.
Do not take this medication if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.
Before taking this medication, tell your doctor if you have
- kidney disease,
- liver disease,
-
diabetes,
-
glaucoma,
-
any type of heart disease or high blood pressure,
-
thyroid disease,
-
emphysema or chronic bronchitis, or
-
difficulty urinating or an enlarged prostate.
You may not be able to take acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.
It is not known whether acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication passes into breast milk and may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions. If you are over 60 years of age, you may be more likely to experience side effects from acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine.
How should I take Contac Severe Cold and Flu Maximum Stength (acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine)?
Take acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water. Do not take more of this medication than is recommended. An overdose of this medication can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage the liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking acetaminophen and never take more than 2 grams (2000 mg) per day.
Do not take acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, see your doctor.
Store acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.
What happens if I overdose?
Seek emergency medical attention.
Symptoms of an acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine overdose include a dry mouth, large pupils, flushing, sweating, nausea, vomiting, diarrhea, abdominal pain, seizures, confusion, an irregular heartbeat, hyperactivity, or hallucinations.
What should I avoid while taking Contac Severe Cold and Flu Maximum Stength (acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine)?
Use caution when driving, operating machinery, or performing other hazardous activities. Acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine. Alcohol may also cause damage to the liver when it is taken with acetaminophen.
Acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine is taken with any of these medications.
Contac Severe Cold and Flu Maximum Stength (acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine) side effects
If you experience any of the following rare but serious side effects, stop taking acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine and seek emergency medical attention or notify your doctor immediately:
-
an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
-
liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, or severe fatigue);
-
blood problems (easy or unusual bleeding or bruising); or
-
low blood sugar (fatigue, increased hunger or thirst, dizziness, or fainting).
Other, less serious side effects may be more likely to occur. Continue to take acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine and talk to your doctor or try another similar medication if you experience
-
dryness of the eyes, nose, and mouth;
-
drowsiness or dizziness;
-
blurred vision;
-
difficulty urinating; or
-
excitation in children.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect Contac Severe Cold and Flu Maximum Stength (acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine)?
Do not take acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.
Urine glucose tests may produce false results while you are taking acetaminophen. Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.
Do not take other over-the-counter cough, cold, allergy, diet, pain, or sleep medicines while taking acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain chlorpheniramine, phenylpropanolamine, acetaminophen, or other similar drugs, and you may accidentally take too much of these medicines.
Acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine is taken with any of these medications.
Drugs other than those listed here may also interact with acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.
Where can I get more information?
- Your pharmacist has additional information about acetaminophen/chlorpheniramine/ dextromethorphan/phenylpropanolamine written for health professionals that you may read.
What does my medication look like?
Acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine is available over the counter under the brand name Comtrex. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
- Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 6.03. Revision Date: 2/13/04 4:05:46 PM.
Contac Severe Cold/
Flu No-Drowsiness
Generic Name: Acetaminophen/Dextromethorphan/Pseudoephedrine (a-seet-a-MIN-oh-fen/dex-troe-meth-OR-fan/sue-doe-eh-FED-rin)
Brand Name: Examples include Contac Severe Cold/Flu No-Drowsiness and Tylenol Flu No Drowsiness
Contac Severe Cold/Flu No-Drowsiness is used for:
Relieving pain, congestion, and cough due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.
Contac Severe Cold/Flu No-Drowsiness is an analgesic, decongestant, and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, which helps you breathe more easily. The analgesic and cough suppressant work in the brain to decrease pain and reduce the cough reflex.
Do NOT use Contac Severe Cold/Flu No-Drowsiness if:
- you are allergic to any ingredient in Contac Severe Cold/Flu No-Drowsiness
- you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)
- you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days
Contact your doctor or health care provider right away if any of these apply to you.
Before using Contac Severe Cold/Flu No-Drowsiness:
Some medical conditions may interact with Contac Severe Cold/Flu No-Drowsiness. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of glaucoma, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, an overactive thyroid, seizures, stroke, or liver problems, or if you consume more than 3 alcohol-containing drinks per day
- if you have a history of asthma, chronic cough, chronic obstructive pulmonary disease (COPD), or other lung problems (eg, chronic bronchitis, emphysema), or if your cough produces large amounts of mucus
Some MEDICINES MAY INTERACT with Contac Severe Cold/Flu No-Drowsiness. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects from Contac Severe Cold/Flu No-Drowsiness may be increased
- Anticoagulants (eg, warfarin), digoxin, or droxidopa because the risk of side effects such as bleeding, irregular heartbeat, or heart attack may be increased
- Bromocriptine because the risk of side effects may be increased by Contac Severe Cold/Flu No-Drowsiness
- Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Contac Severe Cold/Flu No-Drowsiness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Contac Severe Cold/Flu No-Drowsiness may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Contac Severe Cold/Flu No-Drowsiness:
Use Contac Severe Cold/Flu No-Drowsiness as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Contac Severe Cold/Flu No-Drowsiness may be taken with or without food.
- If you miss a dose of Contac Severe Cold/Flu No-Drowsiness, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Contac Severe Cold/Flu No-Drowsiness.
Important safety information:
- Contac Severe Cold/Flu No-Drowsiness may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Contac Severe Cold/Flu No-Drowsiness. Using Contac Severe Cold/Flu No-Drowsiness alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
- Do not take appetite suppressants while you are taking Contac Severe Cold/Flu No-Drowsiness without checking with your doctor.
- Contac Severe Cold/Flu No-Drowsiness contains acetaminophen and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.
- Do NOT exceed the recommended dose or take Contac Severe Cold/Flu No-Drowsiness for longer than prescribed without checking with your doctor.
- If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.
- Contac Severe Cold/Flu No-Drowsiness may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take Contac Severe Cold/Flu No-Drowsiness or other pain relievers/fever reducers. Alcohol use combined with Contac Severe Cold/Flu No-Drowsiness may increase your risk for liver damage.
- Contac Severe Cold/Flu No-Drowsiness may interfere with certain lab test results. Make sure that all of your doctors and lab personnel know that you are taking Contac Severe Cold/Flu No-Drowsiness.
- Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Contac Severe Cold/Flu No-Drowsiness.
- Use Contac Severe Cold/Flu No-Drowsiness with caution in the ELDERLY because they may be more sensitive to its effects.
- Caution is advised when using Contac Severe Cold/Flu No-Drowsiness in CHILDREN because they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Contac Severe Cold/Flu No-Drowsiness, discuss with your doctor the benefits and risks of using Contac Severe Cold/Flu No-Drowsiness during pregnancy. It is unknown if Contac Severe Cold/Flu No-Drowsiness is excreted in breast milk. Do not breast-feed while taking Contac Severe Cold/Flu No-Drowsiness.
Possible side effects of Contac Severe Cold/Flu No-Drowsiness:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; yellowing of skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; stomach pain; unusually fast, slow, or irregular heartbeat; vomiting; yellowing of skin or eyes.
Proper storage of Contac Severe Cold/Flu No-Drowsiness:
Store Contac Severe Cold/Flu No-Drowsiness at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Contac Severe Cold/Flu No-Drowsiness out of the reach of children and away from pets.
General information:
- If you have any questions about Contac Severe Cold/Flu No-Drowsiness, please talk with your doctor, pharmacist, or other health care provider.
- Contac Severe Cold/Flu No-Drowsiness is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Contac Severe Cold/Flu No-Drowsiness. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
