Generic Name: Nystatin (nye-STAT-in)
Brand Name: Mycostatin

Nystatin Suspension is used for:

Treatment of fungal infections of the mouth. It may also be used for other conditions as determined by your doctor.

Nystatin Suspension is an antifungal. It works by weakening cell membranes of the sensitive fungus. This allows the cell contents to leak out and results in death of the fungus.

Do NOT use Nystatin Suspension if:

• you are allergic to any ingredient in Nystatin Suspension

Contact your doctor or health care provider right away if any of these apply to you.

Before using Nystatin Suspension:

Some medical conditions may interact with Nystatin Suspension. 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

Some MEDICINES MAY INTERACT with Nystatin Suspension. However, no specific interactions with Nystatin Suspension are known at this time.

Ask your health care provider if Nystatin Suspension 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 Nystatin Suspension:

Use Nystatin Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Shake well before each use.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If the mouth is affected, place half the dose in each side of the mouth. Swish the medicine around the entire mouth. Retain the dose in your mouth as long as possible before swallowing, unless directed otherwise by your doctor.
• Nystatin Suspension works best if it is taken at the same time every day.
• To clear up your infection completely, take Nystatin Suspension for the full course of treatment. Keep taking it even if you feel better in a few days.
• If you miss a dose of Nystatin Suspension, 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 Nystatin Suspension.

Important safety information:

• Practice good oral hygiene, including proper care of dentures, while you are taking Nystatin Suspension.
• Be sure to use Nystatin Suspension for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Diabetes patients – Nystatin Suspension may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nystatin Suspension while you are pregnant. It is not known if Nystatin Suspension is found in breast milk. If you are or will be breast-feeding while you use Nystatin Suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Nystatin Suspension:

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:

Diarrhea; nausea; stomach irritation; upset stomach; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

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 diarrhea; high blood pressure; nausea; serious irregular heartbeat; vomiting; wheezing.

Proper storage of Nystatin Suspension:

Store Nystatin Suspension at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed, light-resistant container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Nystatin Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Nystatin Suspension, please talk with your doctor, pharmacist, or other health care provider.
• Nystatin Suspension 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 Nystatin Suspension. 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.

Generic Name: Acetaminophen/Dextromethorphan/Doxylamine/Pseudoephedrine (a-seet-a-MIN-oh-fen/dex-troe-meth-OR-fan/dox-IL-a-meen/sue-do-eh-FED-rin)
Brand Name: Examples include Nite-Time Cold/Flu and NyQuil Multi-Symptom

NyQuil Multi-Symptom is used for:

Relieving symptoms of pain, sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

NyQuil Multi-Symptom is a decongestant, antihistamine, cough suppressant, and analgesic combination. It works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The analgesic and cough suppressant work in the brain to decrease pain and to reduce dry or unproductive cough.

Do NOT use NyQuil Multi-Symptom if:

• you are allergic to any ingredient in NyQuil Multi-Symptom
• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
• you are unable to urinate or are having an asthma attack
• you take sodium oxybate (GHB) or 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 NyQuil Multi-Symptom:

Some medical conditions may interact with NyQuil Multi-Symptom. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan 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 fast, slow, or irregular heartbeat
• if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; an overactive thyroid; or liver problems; or if you consume more than 3 alcohol-containing drinks per day
• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with NyQuil Multi-Symptom. 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), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of NyQuil Multi-Symptom may be increased
• Anticoagulants (eg, warfarin), digoxin, or droxidopa because risk of bleeding, irregular heartbeat or heart attack may be increased
• Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by NyQuil Multi-Symptom
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by NyQuil Multi-Symptom

This may not be a complete list of all interactions that may occur. Ask your health care provider if NyQuil Multi-Symptom 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 NyQuil Multi-Symptom:

Use NyQuil Multi-Symptom as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• NyQuil Multi-Symptom may be taken with or without food.
• If you miss a dose of NyQuil Multi-Symptom, 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 NyQuil Multi-Symptom.

Important safety information:

• NyQuil Multi-Symptom may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to NyQuil Multi-Symptom. Using NyQuil Multi-Symptom alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Do not take diet or appetite control medicines while you are taking NyQuil Multi-Symptom without checking with your doctor.
• NyQuil Multi-Symptom 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 NyQuil Multi-Symptom 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.
• NyQuil Multi-Symptom may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to NyQuil Multi-Symptom. Use a sunscreen or protective clothing if you must be outside for a prolonged period.
• NyQuil Multi-Symptom may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take NyQuil Multi-Symptom or other pain relievers/fever reducers. Alcohol use combined with NyQuil Multi-Symptom may increase your risk for liver damage.
• If you are scheduled for allergy skin testing, do not take NyQuil Multi-Symptom for several days before the test because it may decrease your response to the skin tests.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using NyQuil Multi-Symptom.
• Use NyQuil Multi-Symptom with caution in the ELDERLY because they may be more sensitive to its effects.
• Caution is advised when using NyQuil Multi-Symptom in CHILDREN because they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking NyQuil Multi-Symptom, discuss with your doctor the benefits and risks of using NyQuil Multi-Symptom during pregnancy. It is unknown if NyQuil Multi-Symptom is excreted in breast milk. Do not breast-feed while taking NyQuil Multi-Symptom.

Possible side effects of NyQuil Multi-Symptom:

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:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; 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 or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; trouble sleeping; vision changes; 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; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of NyQuil Multi-Symptom:

Store NyQuil Multi-Symptom 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 NyQuil Multi-Symptom out of the reach of children and away from pets.

General information:

• If you have any questions about NyQuil Multi-Symptom, please talk with your doctor, pharmacist, or other health care provider.
• NyQuil Multi-Symptom 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 NyQuil Multi-Symptom. 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.

Generic Name: nystatin (oral) (nye STAH tin)
Brand Names: Bio-Statin, Mycostatin, Mycostatin Pastilles, Nilstat

What is nystatin?

Nystatin is an antifungal medication.

Oral nystatin is used to treat yeast infections of the mouth.

Nystatin may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about nystatin?

Take all of the nystatin that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

What should I discuss with my healthcare provider before taking nystatin?

Nystatin is not absorbed through your stomach. It will not treat fungal infections in any part of your body other than your mouth. Talk to your doctor if you have another type of fungal infection such as athlete’s foot, jock itch, ringworm, or a vaginal yeast infection.

Oral nystatin is in the FDA pregnancy category C. This means that it is not known whether nystatin will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. It is not known whether nystatin will harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take nystatin?

Take nystatin exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take the oral tablets with a full glass of water.

The troches, or pastilles, should be allowed to dissolve in your mouth. Do not chew or swallow them. Suck on one troche at a time until it is completely dissolved.

Shake the suspension well before measuring a dose.

Use a dose-measuring cup, spoon, or dropper to measure the specified dose of the suspension. Swish the suspension around in your mouth, then either spit it out or swallow it, depending upon the instructions given by your doctor.

Take all of the nystatin that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated. Store the Bio-Statin brand of nystatin tablets and powder and the Mycostatin Pastilles in the refrigerator. Store all other nystatin capsules, tablets, and suspension 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 regularly scheduled dose, skip the missed dose and take the next one as directed. 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 nystatin overdose include nausea, stomach upset, vomiting, and diarrhea.

What should I avoid while taking nystatin?

There are no restrictions on foods, beverages, or activities during treatment with nystatin unless your doctor directs otherwise.

Nystatin side effects

Stop taking nystatin 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).

Side effects are not likely to occur with nystatin. Continue to take nystatin and talk to your doctor if you experience

• nausea or stomach upset,

• vomiting, or

• diarrhea.

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.

Nystatin Dosing Information

Usual Adult Dose for Oral Thrush:

1 to 2 oral lozenges (200,000 to 400,000 units) 4 to 5 times a day or
500,000 units of oral suspension 4 times a day.

Usual Adult Dose for Intestinal Candidiasis:

500,000 to 1,000,000 units orally 3 times a day.

Usual Pediatric Dose for Oral Thrush:

Neonates: 100,000 units of oral suspension 4 times a day.
>1 m <12 m:: 200,000 units of oral suspension 4 times a day.
>=1 year <18 years: 1 to 2 oral lozenges (200,000 to 400,000 units) 4 to 5 times a day or 500,000 units of oral suspension 4 times a day.

What other drugs will affect nystatin?

Since nystatin is not absorbed by your body, drug interactions are not expected. Talk to your doctor and pharmacist before taking other prescription or over-the-counter medicines.

Where can I get more information?

• Your pharmacist has additional information about nystatin 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: 3.07. Revision Date: 4/12/2009 4:39:20 PM.

nye-STAT-in

Commonly used brand name(s):

In Canada

• Mycostatin
• Mycostatin Vaginal Cream
• Nadostine
• Nilstat Vaginal Cream
• Nilstat Vaginal Tablet
• Nyaderm Vaginal Cream

Available Dosage Forms:

• Cream
• Tablet

Therapeutic Class: Antifungal

Chemical Class: Polyene

Uses For nystatin

Nystatin belongs to the group of medicines called antifungals. Vaginal nystatin is used to treat fungus infections of the vagina. Nystatin vaginal cream or tablets may also be used for other problems as determined by your doctor.

Nystatin is available only with your doctor’s prescription.

Before Using nystatin

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 nystatin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to nystatin 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

Studies on nystatin have been done only in adults, and there is no specific information comparing use of vaginal nystatin in children with use in other age groups.

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 the use of vaginal nystatin in the elderly with use in other age groups.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Proper Use of nystatin

Nystatin usually comes with patient directions. Read them carefully before using nystatin.

nystatin is usually inserted into the vagina with an applicator. However, if you are pregnant, check with your doctor before using the applicator to insert the vaginal tablet.

To help clear up your infection completely, keep using nystatin for the full time of treatment, even if your condition has improved. Also, keep using nystatin even if you begin to menstruate during the time of treatment. Do not miss any doses.

Dosing

The dose of nystatin 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 nystatin. 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 treating fungus (yeast) infections:
  • For vaginal cream dosage form:
    • Adults and teenagers—One 100,000-unit applicatorful inserted into the vagina one or two times a day for two weeks. Or, your doctor may want you to insert one 500,000-unit applicatorful into the vagina once a day.
    • Children—Dose must be determined by your doctor.
  • For vaginal tablet dosage form:
    • Adults and teenagers—One 100,000-unit tablet inserted into the vagina one or two times a day for two weeks.
    • Children—Dose must be determined by your doctor.

Missed Dose

If you miss a dose of nystatin, 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 nystatin

To help cure the infection and to help prevent reinfection, good health habits are required.

• Wear cotton panties (or panties or pantyhose with cotton crotches) instead of synthetic (for example, nylon, rayon) underclothes.
• Wear freshly laundered underclothes.

If you have any questions about this, check with your health care professional.

If you have any questions about douching or intercourse during the time of treatment with nystatin, check with your doctor.

Since there may be some vaginal drainage while you are using nystatin, a sanitary napkin may be worn to protect your clothing.

nystatin 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

• Vaginal burning or itching not present before use of nystatin

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.

nye-STAT-in

Commonly used brand name(s):

In the U.S.

• Mycostatin
• Nystop
• Pedi-Dri

In Canada

• Mycostatin Cream
• Mycostatin Ointment
• Mycostatin Powder
• Nadostine
• Nilstat Topical Cream
• Nilstat Topical Ointment
• Nyaderm Cream
• Nyaderm Ointment

Available Dosage Forms:

• Powder
• Cream
• Ointment

Therapeutic Class: Antifungal

Chemical Class: Polyene

Uses For nystatin

Nystatin belongs to the group of medicines called antifungals. Topical nystatin is used to treat some types of fungus infections of the skin.

Nystatin is available in the U.S. only with your doctor’s prescription.

Before Using nystatin

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 nystatin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to nystatin 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

Although there is no specific information comparing use of topical nystatin in children with use in other age groups, nystatin is not expected to cause different side effects or problems in children than it does in adults.

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 topical nystatin in the elderly with use in other age groups.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Proper Use of nystatin

Topical nystatin should not be used in the eyes.

Apply enough nystatin to cover the affected area.

For patients using the powder form of nystatin on the feet:

• Sprinkle the powder between the toes, on the feet, and in socks and shoes.

The use of any kind of occlusive dressing (airtight covering, such as kitchen plastic wrap) over nystatin may increase the chance of irritation. Therefore, do not bandage, wrap, or apply any occlusive dressing over nystatin unless directed to do so by your doctor. When using nystatin on the diaper area of children, avoid tight-fitting diapers and plastic pants.

To help clear up your infection completely, keep using nystatin for the full time of treatment, even if your condition has improved. Do not miss any doses.

Dosing

The dose of nystatin 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 nystatin. 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 topical dosage forms (cream or ointment):
  • For fungus infections:
    • Adults and children—Apply to the affected area(s) of the skin two times a day.
• For topical dosage form (powder):
  • For fungus infections:
    • Adults and children—Apply to the affected area(s) of the skin two or three times a day.

Missed Dose

If you miss a dose of nystatin, 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.

nystatin 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:

• Skin irritation not present before use of nystatin

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.

Generic Name: chlorpheniramine, dextromethorphan, and pseudoephedrine (klor feh NEER a meen, dex tro meh THOR fan, and soo doe eh FEH drin)
Brand Names: Creomulsion Cough/Cold/Allergy, Nyquil Child Cough and Cold, Pediacare Cough and Cold, Pediacare Nightrest, Rescon-DM, Rhinosyn-DM, Robitussin Pediatric Night Relief, Triaminic Night Time, Triaminic Softchew Cold and Cough, Vicks 44M Pediatric

What is Nyquil Child Cough and Cold (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

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 signals in the brain that trigger cough reflex.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of chlorpheniramine, dextromethorphan, and pseudoephedrine is used to treat sneezing, runny or stuffy nose, cough, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

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 Nyquil Child Cough and Cold (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

Always ask a doctor before giving a cold or allergy 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, cold, allergy, 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 an antihistamine, decongestant, or cough suppressant. 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. Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

What should I discuss with my healthcare provider before taking Nyquil Child Cough and Cold (chlorpheniramine, dextromethorphan, and 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.

Before taking this medication, tell your doctor if you are allergic to chlorpheniramine, or pseudoephedrine, or if you have:

• kidney disease;

• diabetes;

• glaucoma;

• heart disease or high blood pressure;

• diabetes;

• a thyroid disorder;

• emphysema or chronic bronchitis;

• an enlarged prostate; or

• problems with urination.

If you have any of these conditions, you may not be able to use chlorpheniramine, dextromethorphan, and pseudoephedrine, or you may need a dosage adjustment or special tests during treatment.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Chlorpheniramine, dextromethorphan, and 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 Nyquil Child Cough and Cold (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. Cold medicine is usually taken only for a short time until your symptoms clear up.

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. Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with 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.

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.

Store the medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cough and 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 an overdose may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking Nyquil Child Cough and Cold (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

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 drinking alcohol. It can increase some of the side effects of this medication.

Avoid using other medicines that make you sleepy (such as sleeping pills, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by chlorpheniramine, dextromethorphan, 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 over-the-counter cough, cold, allergy, 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 an antihistamine, decongestant, or cough suppressant.

Nyquil Child Cough and Cold (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, slow, shallow breathing;

• 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);

• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

• urinating less than usual or not at all.

Keep taking the medication and talk to your doctor if you have any of these less serious side effects:

• dry mouth;

• nausea, stomach pain, constipation, mild loss of appetite, upset stomach;

• blurred vision;

• warmth, tingling, or redness under your skin;

• sleep problems (insomnia);

• restless or excitability (especially in children);

• skin rash or itching;

• dizziness, drowsiness, or headache;

• problems with memory or concentration; or

• ringing in your ears.

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 Nyquil Child Cough and Cold (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

• a diuretic (water pill), or blood pressure medicine;

• medication to treat irritable bowel syndrome;

• bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol), darifenacin (Enablex), or tolterodine (Detrol);

• aspirin or salicylates (such as Disalcid, Doan’s Pills, Dolobid, Salflex, Tricosal, and others);

• 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.

If you are using any of these drugs, you may not be able to use chlorpheniramine, dextromethorphan, and pseudoephedrine, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect 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 has information about chlorpheniramine, dextromethorphan, and pseudoephedrine 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: 5.05. Revision Date: 4/12/2009 4:40:57 PM.

Generic Name: acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine (a SEET a MIN o fen, DEX troe meth OR fan, dox IL a meen, SOO doe e FED rin)
Brand Names: Alka-Seltzer Plus Night Time Cold Liquigel, All-Nite Multi-Symptom Cold/Flu Relief, Nyquil Cold Medicine, NyQuil D, Nyquil Hot Therapy, Nyquil Liquicap, Robitussin Night Cold

What is Nyquil Cold Medicine (acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine)?

Acetaminophen is a pain reliever and fever reducer.

Doxylamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms such as sneezing, runny nose, and watery eyes.

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, dextromethorphan, doxylamine, and pseudoephedrine is used to treat runny or stuffy nose, sinus congestion, cough, and pain or fever caused by the common cold, allergies, or the flu.

Dextromethorphan will not treat a cough that is caused by smoking.

Acetaminophen, dextromethorphan, doxylamine, 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 Nyquil Cold Medicine (acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine)?

Always ask your 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 take 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 a cough or cold medicine before the MAO inhibitor has cleared from your body. 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, 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 take to see if it contains acetaminophen (sometimes abbreviated as “APAP”), dextromethorphan, doxylamine, or pseudoephedrine.

What should I discuss with my healthcare provider before taking Nyquil Cold Medicine (acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine)?

Do not use this medication if you are allergic to acetaminophen, dextromethorphan, doxylamine, 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, dextromethorphan, doxylamine, 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;

• enlarged prostate; or

• problems with urination.

FDA pregnancy category C. It is not known whether acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine 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 Nyquil Cold Medicine (acetaminophen, dextromethorphan, doxylamine, 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 to help loosen the congestion and lubricate your throat while you are taking this medication. 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 acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine powder may contain up to 1000 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking. Always ask your 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

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 used this medication 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 Nyquil Cold Medicine (acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine)?

Do not use any other cough, cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”, dextromethorphan, doxylamine and pseudoephedrine are contained in many cold, pain, and sleep medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you take to see if it contains acetaminophen, APAP, dextromethorphan, doxylamine, or pseudoephedrine. Avoid drinking alcohol. It can increase your risk of liver damage while 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 taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with cough or cold medicine can increase your risk of unpleasant side effects.

Nyquil Cold Medicine (acetaminophen, dextromethorphan, doxylamine, 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;

• severe dizziness, anxiety, restless feeling, or nervousness;

• confusion, hallucinations, unusual thoughts or behavior;

• slow, shallow breathing;

• 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:

• mild nausea, upset stomach, constipation;

• warmth, tingling, or redness under your skin;

• sleep problems (insomnia);

• feeling excited or restless; or

• blurred vision, dry mouth;

• problems with memory or concentration;

• ringing in your ears; 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 Nyquil Cold Medicine (acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine)?

Before using this medicine, 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 doxylamine or dextromethorphan.

Also 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);

• medicines to treat high blood pressure;

• gout medication such as probenecid (Benemid);

• an antidepressant;

• a beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta, Ziac), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), and others; or

• seizure medication such as phenytoin (Dilantin) or phenobarbital (Solfoton).

This list is not complete and there may be other drugs that can interact with acetaminophen, dextromethorphan, doxylamine, 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, dextromethorphan, doxylamine, 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: 7.01. Revision Date: 08/07/2009 3:33:40 PM.

Generic Name: acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine (a SEET a MIN o fen, DEX troe meth OR fan, dox IL a meen, SOO doe e FED rin)
Brand Names: Alka-Seltzer Plus Night Time Cold Liquigel, All-Nite Multi-Symptom Cold/Flu Relief, Nyquil Cold Medicine, NyQuil D, Nyquil Hot Therapy, Nyquil Liquicap, Robitussin Night Cold

What is NyQuil D (acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine)?

Acetaminophen is a pain reliever and fever reducer.

Doxylamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms such as sneezing, runny nose, and watery eyes.

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, dextromethorphan, doxylamine, and pseudoephedrine is used to treat runny or stuffy nose, sinus congestion, cough, and pain or fever caused by the common cold, allergies, or the flu.

Dextromethorphan will not treat a cough that is caused by smoking.

Acetaminophen, dextromethorphan, doxylamine, 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 NyQuil D (acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine)?

Always ask your 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 take 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 a cough or cold medicine before the MAO inhibitor has cleared from your body. 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, 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 take to see if it contains acetaminophen (sometimes abbreviated as “APAP”), dextromethorphan, doxylamine, or pseudoephedrine.

What should I discuss with my healthcare provider before taking NyQuil D (acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine)?

Do not use this medication if you are allergic to acetaminophen, dextromethorphan, doxylamine, 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, dextromethorphan, doxylamine, 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;

• enlarged prostate; or

• problems with urination.

FDA pregnancy category C. It is not known whether acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine 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 NyQuil D (acetaminophen, dextromethorphan, doxylamine, 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 to help loosen the congestion and lubricate your throat while you are taking this medication. 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 acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine powder may contain up to 1000 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking. Always ask your 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

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 used this medication 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 NyQuil D (acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine)?

Do not use any other cough, cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”, dextromethorphan, doxylamine and pseudoephedrine are contained in many cold, pain, and sleep medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you take to see if it contains acetaminophen, APAP, dextromethorphan, doxylamine, or pseudoephedrine. Avoid drinking alcohol. It can increase your risk of liver damage while 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 taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with cough or cold medicine can increase your risk of unpleasant side effects.

NyQuil D (acetaminophen, dextromethorphan, doxylamine, 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;

• severe dizziness, anxiety, restless feeling, or nervousness;

• confusion, hallucinations, unusual thoughts or behavior;

• slow, shallow breathing;

• 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:

• mild nausea, upset stomach, constipation;

• warmth, tingling, or redness under your skin;

• sleep problems (insomnia);

• feeling excited or restless; or

• blurred vision, dry mouth;

• problems with memory or concentration;

• ringing in your ears; 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 NyQuil D (acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine)?

Before using this medicine, 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 doxylamine or dextromethorphan.

Also 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);

• medicines to treat high blood pressure;

• gout medication such as probenecid (Benemid);

• an antidepressant;

• a beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta, Ziac), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), and others; or

• seizure medication such as phenytoin (Dilantin) or phenobarbital (Solfoton).

This list is not complete and there may be other drugs that can interact with acetaminophen, dextromethorphan, doxylamine, 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, dextromethorphan, doxylamine, 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: 7.01. Revision Date: 08/07/2009 3:33:40 PM.

Generic Name: acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine (a SEET a MIN o fen, DEX troe meth OR fan, dox IL a meen, SOO doe e FED rin)
Brand Names: Alka-Seltzer Plus Night Time Cold Liquigel, All-Nite Multi-Symptom Cold/Flu Relief, Nyquil Cold Medicine, NyQuil D, Nyquil Hot Therapy, Nyquil Liquicap, Robitussin Night Cold

What is Nyquil Hot Therapy (acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine)?

Acetaminophen is a pain reliever and fever reducer.

Doxylamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms such as sneezing, runny nose, and watery eyes.

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, dextromethorphan, doxylamine, and pseudoephedrine is used to treat runny or stuffy nose, sinus congestion, cough, and pain or fever caused by the common cold, allergies, or the flu.

Dextromethorphan will not treat a cough that is caused by smoking.

Acetaminophen, dextromethorphan, doxylamine, 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 Nyquil Hot Therapy (acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine)?

Always ask your 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 take 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 a cough or cold medicine before the MAO inhibitor has cleared from your body. 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, 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 take to see if it contains acetaminophen (sometimes abbreviated as “APAP”), dextromethorphan, doxylamine, or pseudoephedrine.

What should I discuss with my healthcare provider before taking Nyquil Hot Therapy (acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine)?

Do not use this medication if you are allergic to acetaminophen, dextromethorphan, doxylamine, 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, dextromethorphan, doxylamine, 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;

• enlarged prostate; or

• problems with urination.

FDA pregnancy category C. It is not known whether acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine 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 Nyquil Hot Therapy (acetaminophen, dextromethorphan, doxylamine, 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 to help loosen the congestion and lubricate your throat while you are taking this medication. 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 acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine powder may contain up to 1000 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking. Always ask your 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

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 used this medication 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 Nyquil Hot Therapy (acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine)?

Do not use any other cough, cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”, dextromethorphan, doxylamine and pseudoephedrine are contained in many cold, pain, and sleep medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you take to see if it contains acetaminophen, APAP, dextromethorphan, doxylamine, or pseudoephedrine. Avoid drinking alcohol. It can increase your risk of liver damage while 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 taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with cough or cold medicine can increase your risk of unpleasant side effects.

Nyquil Hot Therapy (acetaminophen, dextromethorphan, doxylamine, 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;

• severe dizziness, anxiety, restless feeling, or nervousness;

• confusion, hallucinations, unusual thoughts or behavior;

• slow, shallow breathing;

• 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:

• mild nausea, upset stomach, constipation;

• warmth, tingling, or redness under your skin;

• sleep problems (insomnia);

• feeling excited or restless; or

• blurred vision, dry mouth;

• problems with memory or concentration;

• ringing in your ears; 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 Nyquil Hot Therapy (acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine)?

Before using this medicine, 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 doxylamine or dextromethorphan.

Also 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);

• medicines to treat high blood pressure;

• gout medication such as probenecid (Benemid);

• an antidepressant;

• a beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta, Ziac), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), and others; or

• seizure medication such as phenytoin (Dilantin) or phenobarbital (Solfoton).

This list is not complete and there may be other drugs that can interact with acetaminophen, dextromethorphan, doxylamine, 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, dextromethorphan, doxylamine, 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: 7.01. Revision Date: 08/07/2009 3:33:40 PM.

Generic Name: acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine (a SEET a MIN o fen, DEX troe meth OR fan, dox IL a meen, SOO doe e FED rin)
Brand Names: Alka-Seltzer Plus Night Time Cold Liquigel, All-Nite Multi-Symptom Cold/Flu Relief, Nyquil Cold Medicine, NyQuil D, Nyquil Hot Therapy, Nyquil Liquicap, Robitussin Night Cold

What is Nyquil Liquicap (acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine)?

Acetaminophen is a pain reliever and fever reducer.

Doxylamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms such as sneezing, runny nose, and watery eyes.

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, dextromethorphan, doxylamine, and pseudoephedrine is used to treat runny or stuffy nose, sinus congestion, cough, and pain or fever caused by the common cold, allergies, or the flu.

Dextromethorphan will not treat a cough that is caused by smoking.

Acetaminophen, dextromethorphan, doxylamine, 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 Nyquil Liquicap (acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine)?

Always ask your 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 take 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 a cough or cold medicine before the MAO inhibitor has cleared from your body. 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, 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 take to see if it contains acetaminophen (sometimes abbreviated as “APAP”), dextromethorphan, doxylamine, or pseudoephedrine.

What should I discuss with my healthcare provider before taking Nyquil Liquicap (acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine)?

Do not use this medication if you are allergic to acetaminophen, dextromethorphan, doxylamine, 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, dextromethorphan, doxylamine, 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;

• enlarged prostate; or

• problems with urination.

FDA pregnancy category C. It is not known whether acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine 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 Nyquil Liquicap (acetaminophen, dextromethorphan, doxylamine, 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 to help loosen the congestion and lubricate your throat while you are taking this medication. 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 acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine powder may contain up to 1000 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking. Always ask your 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

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 used this medication 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 Nyquil Liquicap (acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine)?

Do not use any other cough, cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”, dextromethorphan, doxylamine and pseudoephedrine are contained in many cold, pain, and sleep medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you take to see if it contains acetaminophen, APAP, dextromethorphan, doxylamine, or pseudoephedrine. Avoid drinking alcohol. It can increase your risk of liver damage while 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 taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with cough or cold medicine can increase your risk of unpleasant side effects.

Nyquil Liquicap (acetaminophen, dextromethorphan, doxylamine, 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;

• severe dizziness, anxiety, restless feeling, or nervousness;

• confusion, hallucinations, unusual thoughts or behavior;

• slow, shallow breathing;

• 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:

• mild nausea, upset stomach, constipation;

• warmth, tingling, or redness under your skin;

• sleep problems (insomnia);

• feeling excited or restless; or

• blurred vision, dry mouth;

• problems with memory or concentration;

• ringing in your ears; 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 Nyquil Liquicap (acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine)?

Before using this medicine, 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 doxylamine or dextromethorphan.

Also 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);

• medicines to treat high blood pressure;

• gout medication such as probenecid (Benemid);

• an antidepressant;

• a beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta, Ziac), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), and others; or

• seizure medication such as phenytoin (Dilantin) or phenobarbital (Solfoton).

This list is not complete and there may be other drugs that can interact with acetaminophen, dextromethorphan, doxylamine, 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, dextromethorphan, doxylamine, 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: 7.01. Revision Date: 08/07/2009 3:33:40 PM.