Generic Name: hepatitis A and hepatitis B vaccine (HEP a TYE tis)
Brand Names: Twinrix

What is Twinrix (hepatitis A and hepatitis B vaccine)?

Hepatitis A and B are serious diseases caused by virus.

Hepatitis A is spread through contact with the stool (bowel movements) of a person infected with the hepatitis A virus. This usually occurs by eating food or drinking water that has become contaminated as a result of handling by an infected person.

Hepatitis B is spread through blood or bodily fluids, sexual contact or sharing IV drug needles with an infected person, or during childbirth when a baby is born to a mother who is infected.

Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.

The hepatitis A and hepatitis B vaccine is used to help prevent these diseases. The vaccine works by exposing you to a small dose of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Vaccination with hepatitis A and hepatitis B is recommended for all adults who are at risk of getting hepatitis A or B. Risk factors include: having more than one sex partner in 6 months; being a homosexual male; having sexual contact with infected people; having cirrhosis or chronic hepatitis C; using intravenous (IV) drugs; being on dialysis or receiving blood transfusions; working in healthcare or public safety and being exposed to infected blood or body fluids; being in the military or traveling to high-risk areas; and living with a person who has either hepatitis A or B infection.

Like any vaccine, the hepatitis A and hepatitis B vaccine may not provide protection from disease in every person.

What is the most important information I should know about this vaccine?

You should not receive this vaccine if you are allergic to yeast or neomycin (Mycafradin, Neo-Fradin, Neo-Tab), or if you have ever had a life-threatening allergic reaction to any vaccine containing hepatitis A or hepatitis B.

Before receiving this vaccine, tell the doctor if you have multiple sclerosis, a bleeding or blood clotting disorder, seizures, a weak immune system, if you are taking a blood thinner, or if you are allergic to rubber.

Vaccination with hepatitis A and hepatitis B is recommended for all adults who are at risk of getting hepatitis A or B. Risk factors include: having more than one sex partner in 6 months; being a homosexual male; having sexual contact with infected people; having cirrhosis or chronic hepatitis C; using intravenous (IV) drugs; being on dialysis or receiving blood transfusions; working in healthcare or public safety and being exposed to infected blood or body fluids; being in the military or traveling to high-risk areas; and living with a person who has either hepatitis A or B infection.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Hepatitis A and hepatitis B vaccine will not protect you against infection with hepatitis C or E, or other viruses that affect the liver. It will also not protect you from hepatitis if you are already infected with the virus, even if you do not yet show symptoms.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with hepatitis A or B is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

What should I discuss with my healthcare provider before receiving this vaccine?

Hepatitis A and hepatitis B vaccine will not protect you against infection with hepatitis C or E, or other viruses that affect the liver. It will also not protect you from hepatitis A or B if you are already infected with the virus, even if you do not yet show symptoms.

You should not receive this vaccine if you are allergic to yeast or neomycin (Mycafradin, Neo-Fradin, Neo-Tab), or if you have ever had a life-threatening allergic reaction to any vaccine containing hepatitis A or hepatitis B.

Before receiving this vaccine, tell the doctor if you have:

• multiple sclerosis;

• a bleeding or blood clotting disorder such as hemophilia or easy bruising;

• a history of seizures;

• an allergy to latex rubber;

• a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or

• if you are taking a blood thinner such as warfarin (Coumadin).

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

FDA pregnancy category C. It is not known whether hepatitis A and hepatitis B vaccine is harmful to an unborn baby. Before receiving this vaccine, tell your doctor if you are pregnant. It is not known whether hepatitis A and hepatitis B vaccine passes into breast milk or if it could harm a nursing baby. Do not receive this vaccine without telling your doctor if you are breast-feeding a baby.

How is this vaccine given?

This vaccine is given as an injection (shot) into a muscle. You will receive this injection in a doctor’s office or other clinic setting.

The hepatitis A and hepatitis B vaccine is given in a series of shots. The booster shots are sometimes given 1 month and 6 months after the first shot.

If you have a high risk of hepatitis infection, you may be given 3 shots within 30 days of each other, and a fourth shot 12 months after the first.

Your individual booster schedule may be different from these guidelines. Follow your doctor’s instructions or the schedule recommended by the health department of the state you live in.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor’s instructions about how much of this medicine to take.

It is especially important to prevent fever from occurring if you have a seizure disorder such as epilepsy.

What happens if I miss a dose?

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

This vaccine side effects

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot. Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with hepatitis A or B is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

• fast or pounding heartbeats; or

• easy bruising or bleeding.

Less serious side effects include:

• redness, pain, tenderness, swelling, or a hard lump where the shot was given;

• headache, tired feeling;

• mild fever;

• runny or stuffy nose, sore throat, other cold symptoms; or

• nausea, vomiting, loss of appetite, diarrhea.

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 vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

What other drugs will affect Twinrix (hepatitis A and hepatitis B vaccine)?

Before receiving this vaccine, tell the doctor about all other vaccines you have recently received.

Also tell the doctor if you have received drugs or treatments in the past 2 weeks that can weaken the immune system, including:

• an oral, nasal, inhaled, or injectable steroid medicine;

• medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or

• medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

This list is not complete and there may be other drugs that can interact with hepatitis A and hepatitis B vaccine. Tell your doctor about all the prescription and over-the-counter medications you have received. 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 doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.

• 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: 2.01. Revision Date: 05/29/2009 2:40:41 PM.

Generic Name: epinephrine (Injection route)

ep-i-NEF-rin

Commonly used brand name(s):

In the U.S.

• Adrenaclick
• Adrenalin
• Adrenalin Chloride
• Epipen
• Epipen Jr
• Twinject

Available Dosage Forms:

• Injectable
• Solution

Therapeutic Class: Anaphylaxis Agent

Pharmacologic Class: Adrenergic

Chemical Class: Alkylarylamine

Uses For Twinject

Epinephrine injection is used for emergency treatment of severe allergic reactions (including anaphylaxis) to insect bites or stings, medicines, foods, or other substances. It is also used to treat anaphylaxis caused by unknown substances or triggered by exercise.

This medicine is available only with your doctor’s prescription.

Before Using Twinject

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

No information is available on the relationship of age to the effects of epinephrine injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of epinephrine injection in geriatric patients. However, elderly patients are more likely to have age-related heart disease which may require caution in patients receiving epinephrine injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dihydroergotamine
• Isocarboxazid
• Linezolid
• Phenelzine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amitriptyline
• Amoxapine
• Bucindolol
• Carteolol
• Carvedilol
• Clomipramine
• Desipramine
• Dilevalol
• Dothiepin
• Doxepin
• Entacapone
• Halothane
• Imipramine
• Levobunolol
• Lofepramine
• Metipranolol
• Nadolol
• Nortriptyline
• Opipramol
• Oxprenolol
• Penbutolol
• Pindolol
• Propranolol
• Protriptyline
• Sotalol
• Tertatolol
• Timolol
• Trimipramine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Labetalol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina pectoris (severe chest pain) or
• Blood vessel problems or
• Diabetes mellitus (sugar diabetes) or
• Heart attack or
• Heart disease or
• Heart rhythm problems or
• Hypertension (high blood pressure) or
• Overactive thyroid or
• Parkinson’s disease—Use with caution. May make these conditions worse.

Proper Use of epinephrine

This section provides information on the proper use of a number of products that contain epinephrine. It may not be specific to Twinject. Please read with care.

Use this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

If you are using this medicine at home, make sure you or any of your family members understand exactly how to give them. Also, tell your doctor if you or your caregiver has severe arthritis of the hands. If you have any questions about this, check with your doctor.

This medicine is injected under your skin or into the muscle of your outer thigh only. Do not inject this medicine into a vein or into the muscle of your buttocks. To do so, may increase the chance of having serious side effects.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine comes in an auto-injector syringe and needle kit that contains the correct dose of medicine your doctor has prescribed.

You may need to use more than one injection if your allergic reaction does not get better after the first shot.

Carry this medicine with you at all times for emergency use in case you have a severe allergic reaction.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For allergic reactions:
    • Adults and children weighing above 30 kilograms (66 pounds)—0.3 milligram (mg) injected under the skin or into the muscle of your thigh.
    • Adults and children weighing 15 to 30 kilograms (33 to 66 pounds)—0.15 milligram (mg) injected under the skin or into the muscle of your thigh.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store the injection kits at room temperature, away from heat, moisture, and direct light. Do not store the medicine in the refrigerator or freezer. Keep the auto-injector in its case or tube.

Check the injection kits regularly to make sure that the liquid has not changed its color. Do not use this medicine if the liquid has changed its color, or if there are solids in the liquid.

Do not reuse the remaining portion of the medicine that is left in the auto-injector. Throw away the auto-injector after you have used it.

Precautions While Using Twinject

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Anaphylaxis is a life-threatening reaction and requires immediate medical attention. Check with your doctor right away, or go to an emergency room as soon as possible, even if you feel better after using this medicine.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Do not inject this medicine into your hands or feet. There is already less blood flow to the hands and feet, and epinephrine could make that worse and cause damage to these tissues. If you accidentally inject epinephrine into your hands or feet, check with your doctor or go to the hospital emergency room right away.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Twinject 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 immediately if any of the following side effects occur:

Incidence not known

• Abnormal or decreased touch sensation
• arm, back or jaw pain
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• blurred vision
• chest pain or discomfort
• chest tightness or heaviness
• dizziness
• fainting fast, irregular, pounding, or racing heartbeat or pulse
• fear or nervousness
• headache
• nausea or vomiting
• paleness of the skin
• pounding in the ears
• restlessness
• shakiness in the legs, arms, hands, or feet
• shortness of breath
• slow or fast heartbeat
• stroke
• sweating
• trembling or shaking of the hands or feet
• troubled breathing
• unusual tiredness or weakness
• wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Agitation
• coldness of the skin
• coma
• confusion
• decreased urine output
• depression
• drowsiness
• hostility
• irritability
• lethargy
• lightheadedness, dizziness, or fainting
• muscle twitching
• pounding, slow heartbeat
• rapid weight gain
• rapid, deep breathing
• seizures
• stomach cramps
• stupor
• swelling of the face, ankles, or hands

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.

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Generic Name: Epinephrine (EP-i-NEF-rin)
Brand Name: Adrenaclick or Twinject

Twinject Auto-Injector is used for:

Treating severe allergic reactions (eg, difficulty breathing; rash; hives; itching; tightness in the chest; swelling of the mouth, lips, or tongue) caused by insect stings or bites, foods, drugs, or other causes. It may also be used for other conditions as determined by your doctor.

Twinject Auto-Injector is a sympathomimetic. It works on different receptors in the body to relax the smooth muscle of the lungs, which improves breathing. It also blocks histamine, which decreases rash, hives, and swelling.

Do NOT use Twinject Auto-Injector if:

• you are allergic to any ingredient in Twinject Auto-Injector, unless your doctor tells you otherwise

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

Before using Twinject Auto-Injector:

Some medical conditions may interact with Twinject Auto-Injector. 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 (eg, sulfites)
• if you have glaucoma, heart disease, chest pain, high blood pressure, blood vessel problems, diabetes, Parkinson disease, thyroid problems, mood or mental disorders, depression, asthma, or an irregular heartbeat

Some MEDICINES MAY INTERACT with Twinject Auto-Injector. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Alpha-blockers (eg, prazosin), beta-blockers (eg, propanolol), droxidopa, ergot alkaloids (eg, ergotamine), or phenothiazines (eg, chlorpromazine) because the risk of high or low blood pressure and fast or slow heartbeat may be increased
• Bromocriptine, furazolidone, linezolid, or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects, such as headache, high temperature, and high blood pressure, may be increased
• Antihistamines (eg, diphenhydramine), catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), digoxin, diuretics (eg, furosemide, hydrochlorothiazide), levothyroxine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), or medicines for irregular heartbeat (eg, quinidine) because they may increase the risk of Twinject Auto-Injector’s side effects
• Guanethidine because its effectiveness may be decreased by Twinject Auto-Injector

This may not be a complete list of all interactions that may occur. Ask your health care provider if Twinject Auto-Injector 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 Twinject Auto-Injector:

Use Twinject Auto-Injector as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Twinject Auto-Injector. Talk to your pharmacist if you have questions about this information.
• Twinject Auto-Injector may be given as an injection at your doctor’s office, hospital, or clinic. If you will be using Twinject Auto-Injector at home, a health care provider will teach you how to use it. Be sure you understand how to use Twinject Auto-Injector. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Check Twinject Auto-Injector regularly. Replace the injector unit if it contains particles, is discolored (pink or brown), or is cracked or damaged in any way.
• Inject Twinject Auto-Injector only into the outer thigh. Do not inject into the buttocks or into a vein.
• Immediately after use, go to the nearest hospital emergency room. You may need further medical attention. Tell the doctor or health care provider that you have received an injection of epinephrine. Show the thigh where the injection was given to the doctor. Give your used auto-injector to the doctor for inspection and proper disposal.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• Twinject Auto-Injector is usually given as a one-time dose in an emergency situation. If you are unable to use Twinject Auto-Injector, seek medical attention immediately.
• If you miss a dose of Twinject Auto-Injector, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Twinject Auto-Injector.

Important safety information:

• Never put your thumb, fingers, or hand over the red tip of the auto-injector. Do NOT remove the green or red cap until ready to use.
• Only inject Twinject Auto-Injector into the outer thigh. Never inject Twinject Auto-Injector into hands, fingers, feet, or toes. Doing so may cause a loss of blood flow and result in tissue damage to these areas. If you accidentally inject Twinject Auto-Injector into any of these areas, seek immediate emergency medical attention.
• It may be helpful to train others how to give Twinject Auto-Injector in case you are unable to give it to yourself during a reaction.
• Diabetes patients – Twinject Auto-Injector may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
• Patients with Parkinson disease may notice a temporary worsening of symptoms (eg, uncontrolled muscle movements). If these symptoms persist, contact your doctor.
• Use Twinject Auto-Injector with caution in the ELDERLY; they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Twinject Auto-Injector while you are pregnant. It is not known if Twinject Auto-Injector is found in breast milk. If you are or will be breast-feeding while you use Twinject Auto-Injector, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Twinject Auto-Injector:

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:

Anxiety; difficulty sleeping; dizziness; fearfulness; headache; nausea; nervousness; paleness; sweating; tremors; vomiting; weakness.

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); chest pain; fast or irregular heartbeat; wheezing.

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 chest pain; extreme paleness or coldness of the skin; fast or irregular heartbeat; one-sided weakness; severe headache or dizziness; trouble breathing.

Proper storage of Twinject Auto-Injector:

Store Twinject Auto-Injector at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in the carrying case provided. Do not refrigerate or freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Twinject Auto-Injector out of the reach of children and away from pets.

General information:

• If you have any questions about Twinject Auto-Injector, please talk with your doctor, pharmacist, or other health care provider.
• Twinject Auto-Injector 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 Twinject Auto-Injector. 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: carbetapentane and chlorpheniramine (kar BET a PEN tane and KLOR fen IR a meen)
Brand Names: C-Tanna 12, Tannate 12 S, Tannic-12 S, Trionate, Tussi-12, Tussi-12S, Tussizone-12 RF, Tustan 12S

What is Tustan 12S (carbetapentane and chlorpheniramine)?

Carbetapentane is a cough suppressant.

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.

The combination of carbetapentane and chlorpheniramine is used to treat runny nose, sneezing, watery eyes, and cough caused by allergies, the common cold, or the flu.

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

Carbetapentane and chlorpheniramine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Tustan 12S (carbetapentane and chlorpheniramine)?

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. 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.

Before using this medication, tell your doctor if you have heart disease, high blood pressure, emphysema, chronic bronchitis, a seizure disorder, glaucoma, kidney disease, a thyroid disorder, enlarged prostate, problems with urination, or any drug or food allergies.

Avoid drinking alcohol while you are taking carbetapentane and chlorpheniramine.

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 one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine or cough suppressant.

What should I discuss with my healthcare provider before taking Tustan 12S (carbetapentane and chlorpheniramine)?

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. You should not use this medication if you are allergic to carbetapentane or chlorpheniramine, or to other antihistamines.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have:

• heart disease, high blood pressure;

• emphysema, chronic bronchitis, or other breathing problems;

• glaucoma;

• kidney disease;

• epilepsy or other seizure disorder;

• a thyroid disorder;

• an enlarged prostate;

• problems with urination; or

• if you are allergic to yellow food dye.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Tustan 12S (carbetapentane and chlorpheniramine)?

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 medicine is usually taken only for a short time until your symptoms clear up.

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. 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. Drink plenty of fluids to help loosen mucus congestion while you are taking this medication.

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.

Talk with your doctor if your symptoms do not improve, or if they get worse after using this medication. Store the medicine at room temperature away from moisture and heat.

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, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include 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 Tustan 12S (carbetapentane and chlorpheniramine)?

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. Narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by carbetapentane and chlorpheniramine. Tell your doctor if you regularly use any of these medicines, or any other cold or allergy medications. Avoid drinking alcohol while you are taking this medication. Alcohol can add to drowsiness caused by an carbetapentane and chlorpheniramine.

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 one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine or cough suppressant.

Tustan 12S (carbetapentane and chlorpheniramine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• fast, pounding, or uneven heartbeat;

• confusion, unusual thoughts or behavior, seizure (convulsions);

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

• urinating less than usual or not at all; or

• slow, shallow breathing.

Less serious side effects may include:

• dizziness, drowsiness;

• blurred vision;

• dry mouth, nose, or eyes; or

• nausea, stomach pain, constipation, loss of appetite.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Tustan 12S (carbetapentane and chlorpheniramine)?

Many drugs can interact with carbetapentane and chlorpheniramine. Below is just a partial list. Tell your doctor if you are using:

• an antidepressant;

• a diuretic (water pill);

• medication to treat irritable bowel syndrome; or

• bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol).

This list is not complete and there may be other drugs that can interact with carbetapentane and chlorpheniramine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about carbetapentane and chlorpheniramine.

• 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: 1.02. Revision Date: 4/12/2009 4:44:40 PM.

Generic Name: oxymetazoline nasal (ox ee me TAZ oh leen)
Brand Names: Afrin, Afrin Nasal Sinus, Allerest 12 Hour Nasal Spray, Duramist Plus, Duration, Four-Way Nasal Spray, Genasal, Neo-Synephrine 12 Hour, Nostrilla, NRS Nasal, NTZ Long Acting Nasal, Oxyfrin, Oxymeta-12, Sinarest Nasal, Sinex Long-Acting, Twice-A-Day

What is Twice-A-Day (oxymetazoline nasal)?

Oxymetazoline is a decongestant. It works by constricting (shrinking) blood vessels (veins and arteries) in your body. The nasal formulation acts directly on the blood vessels in your nasal tissues. Constriction of the blood vessels in your nose and sinuses leads to drainage of these areas and a decrease in congestion.

Oxymetazoline nasal is used to treat congestion associated with allergies, hay fever, sinus irritation, and the common cold.

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

What is the most important information I should know about Twice-A-Day (oxymetazoline nasal)?

Do not use oxymetazoline nasal for longer than 3 to 5 days. Longer use could cause damage to your nasal tissue and lead to chronic congestion. If your symptoms do not improve, see your doctor.

Do not use more of this medication than is recommended on the package or by your doctor.

Who should not use Twice-A-Day (oxymetazoline nasal)?

Do not use oxymetazoline nasal if you have taken a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. This could cause a very dangerous drug interaction with serious side effects.

Before taking this medication, tell your doctor if you have

• high blood pressure;

• any type of heart disease, hardening of the arteries, or irregular heart beats;

• thyroid problems;

• diabetes;

• glaucoma or increased pressure in the eye;

• an enlarged prostate or difficulty urinating; or

• liver or kidney disease.

You may not be able to use oxymetazoline nasal, or you may require a lower dose or special monitoring during your therapy if you have any of the conditions listed above.

It is not known whether oxymetazoline nasal will harm an unborn baby. Do not use oxymetazoline nasal without first talking to your doctor if you are pregnant. Infants are especially sensitive to the effects of oxymetazoline nasal. Do not use this medication without first talking to your doctor if you are breast-feeding a baby. If you over 60 years of age, you may be more likely to experience side effects from oxymetazoline nasal. You may require a lower dose of this medication.

How should I use Twice-A-Day (oxymetazoline nasal)?

Use oxymetazoline nasal exactly as directed by your doctor, or follow the instructions that accompany the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

To apply the nasal spray, keep your head upright, spray, then sniff hard for a few minutes after administering a dose.

To apply the nasal drops, lie on a bed on your back with your head hanging over the edge. Insert the drops and remain in this position for several minutes. Gently turn your head from side to side.

Do not allow the tip of the container to touch the inside of your nose or any other surface. This spreads the infection.

Also, to prevent the spread of infection, do not share this medication with anyone else.

Discard this medication bottle after use. Do not save it for reuse.

Never use this medication in larger doses or more often than is recommended. Too much oxymetazoline nasal could be very harmful. Oxymetazoline nasal should not be used more often than twice a day (every 12 hours).

Do not use oxymetazoline nasal for longer than 3 to 5 days. Longer use could cause damage to your nasal tissue and lead to chronic congestion. If your symptoms do not improve, see your doctor.

Store oxymetazoline nasal at room temperature away from moisture and heat.

What happens if I miss a dose?

Use 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 use the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an oxymetazoline nasal overdose include extreme tiredness, sweating, dizziness, a slow heartbeat, and coma.

What should I avoid while taking Twice-A-Day (oxymetazoline nasal)?

Never use this medication in larger doses or more often than is recommended. Too much oxymetazoline nasal could be very harmful.

Twice-A-Day (oxymetazoline nasal) side effects

If you experience any of the following serious side effects, stop using oxymetazoline nasal and seek emergency medical attention:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

• seizures;

• unusual behavior or hallucinations; or

• an irregular or fast heartbeat.

More commonly, you may experience some sneezing or burning, stinging, dryness, or irritation of the nose. These side effects are usually mild and temporary.

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 Twice-A-Day (oxymetazoline nasal)?

Do not use oxymetazoline nasal if you have taken a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days.

Although drug interactions between topical nasal decongestants and drugs taken by mouth are not expected, they can occur. Rarely, oxymetazoline nasal may interact with the following medicines:

• furazolidone (Furoxone);

• guanethidine (Ismelin);

• indomethacin (Indocin);

• methyldopa (Aldomet);

• bromocriptine (Parlodel);

• caffeine in cola, tea, coffee, chocolate and other products;

• theophylline (Theo-Dur, Theochron, Theolair, others);

• tricyclic antidepressants such as amitriptyline (Elavil, Endep), doxepin (Sinequan), and nortriptyline (Pamelor);
• other commonly used tricyclic antidepressants, including amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), protriptyline (Vivactil), and trimipramine (Surmontil);
• phenothiazines such as chlorpromazine (Thorazine), thioridazine (Mellaril), and prochlorperazine (Compazine); and
• other commonly used phenothiazines, including fluphenazine (Prolixin), perphenazine (Trilafon), mesoridazine (Serentil), and trifluoperazine (Stelazine).

Drugs other than those listed here may also interact with oxymetazoline nasal. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

• Your pharmacist has additional information about oxymetazoline nasal 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: 3.04. Revision Date: 4/12/2009 4:38:11 PM.

Generic Name: diphenhydramine (DYE fen HYE dra meen)
Brand Names: Aler-Tab, Allergy, Allermax, Altaryl, Benadryl Allergy, Benadryl DF, Benadryl Dye Free Allergy, Benadryl Ultratab, Children’s Allergy, Diphen Cough, Diphenhist, Dytuss, PediaCare Children’s Allergy, Q-Dryl, Q-Dryl A/F, Siladryl, Siladryl Allergy, Silphen Cough, Simply Sleep, Sleep-ettes, Sleep-ettes D, Sominex Maximum Strength Caplet, Theraflu Thin Strips Multi Symptom, Triaminic Thin Strips Cough & Runny Nose, Unisom Sleepgels Maximum Strength, Valu-Dryl

What is Twilite (diphenhydramine)?

Diphenhydramine is an antihistamine. Diphenhydramine blocks the effects of the naturally occurring chemical histamine in the body.

Diphenhydramine is used to treat sneezing; runny nose; itching, watery eyes; hives; rashes; itching; and other symptoms of allergies and the common cold.

Diphenhydramine is also used to suppress coughs, to treat motion sickness, to induce sleep, and to treat mild forms of Parkinson’s disease.

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

What is the most important information I should know about Twilite (diphenhydramine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Diphenhydramine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking diphenhydramine.

What should I discuss with my healthcare provider before taking Twilite (diphenhydramine)?

Do not take diphenhydramine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• glaucoma or increased pressure in the eye;

• a stomach ulcer;

• an enlarged prostate, bladder problems or difficulty urinating;

• an overactive thyroid (hyperthyroidism);

• hypertension or any type of heart problems; or

• asthma.

You may not be able to take diphenhydramine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

Diphenhydramine is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not take diphenhydramine without first talking to your doctor if you are pregnant. Infants are especially sensitive to the effects of antihistamines, and side effects could occur in a breast-feeding baby. Do not take diphenhydramine without first talking to your doctor if you are nursing a baby. If you are over 60 years of age, you may be more likely to experience side effects from diphenhydramine. You may require a lower dose of this medication.

How should I take Twilite (diphenhydramine)?

Take diphenhydramine exactly as directed on the package or as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Diphenhydramine can be taken with or without food.

For motion sickness, a dose is usually taken 30 minutes before motion, then with meals and at bedtime for the duration of exposure.

As a sleep aid, diphenhydramine should be taken approximately 30 minutes before bedtime.

To ensure that you get a correct dose, measure the liquid forms of diphenhydramine with a special dose-measuring spoon or cup, not with a regular tablespoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Never take more of this medication than is prescribed for you. The maximum amount of diphenhydramine that you should take in any 24-hour period is 300 mg.

Store diphenhydramine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a diphenhydramine overdose include extreme sleepiness, confusion, weakness, ringing in the ears, blurred vision, large pupils, dry mouth, flushing, fever, shaking, insomnia, hallucinations, and possibly seizures.

What should I avoid while taking Twilite (diphenhydramine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Diphenhydramine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking diphenhydramine.

Twilite (diphenhydramine) side effects

Stop taking diphenhydramine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take diphenhydramine and talk to your doctor if you experience

• sleepiness, fatigue, or dizziness;

• headache;

• dry mouth; or

• difficulty urinating or an enlarged prostate.

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 Twilite (diphenhydramine)?

Do not take diphenhydramine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Talk to your pharmacist before taking other over-the-counter cough, cold, allergy, or insomnia medications. These products may contain medicines similar to diphenhydramine, which could lead to an antihistamine overdose.

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

• anxiety or sleep medicines such as alprazolam (Xanax), diazepam (Valium), chlordiazepoxide (Librium), temazepam (Restoril), or triazolam (Halcion);

• medications for depression such as amitriptyline (Elavil), doxepin (Sinequan), nortriptyline (Pamelor), fluoxetine (Prozac), sertraline (Zoloft), or paroxetine (Paxil); or

• any other medications that make you feel drowsy, sleepy, or relaxed.

Drugs other than those listed here may also interact with diphenhydramine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

• Your pharmacist can provide more information about diphenhydramine.

• 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: 5.01. Revision Date: 04/02/2009 3:16:39 PM.

Generic Name: carbetapentane and guaifenesin ( kar BET a PEN tane, and gwye FEN e sin)
Brand Names: Allfen C, Allfen CX, Allres-G, BetaVent, Carba-XP, Certuss, Duratuss CS, exall, Oratuss, Pulmari-GP, Respi-Tann G, Tusso-ZMR, Tusso-ZR, Xpect-AT

What is Tusso-ZR (carbetapentane and guaifenesin)?

Carbetapentane is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Guaifenesin is an expectorant. It helps loosen mucus congestion in your chest and throat, making it easier to cough out through your mouth.

The combination of carbetapentane and guaifenesin is used to treat stuffy nose, cough, and chest congestion caused by the common cold or flu.

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

Carbetapentane and guaifenesin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Tusso-ZR (carbetapentane and guaifenesin)?

You should not use this medication if you are allergic to carbetapentane or guaifenesin. Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use 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.

Before you take carbetapentane and guaifenesin, tell your doctor if you have asthma or other breathing disorder, heart disease, high blood pressure, glaucoma, diabetes, urination problems, an overactive thyroid, or if you are allergic to any drugs or foods.

Also tell your doctor about all other medications you use.

This medication can cause side effects that may cause drowsiness, dizziness, or blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Talk with your doctor if your symptoms do not improve after 7 days of taking this medication. Call your doctor any time if your symptoms get worse or if you also have a fever, headache, or skin rash.

What should I discuss with my health care provider before taking Tusso-ZR (carbetapentane and guaifenesin)?

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 a cough or cold medicine before the MAO inhibitor has cleared from your body. You should not use this medication if you are allergic to carbetapentane or guaifenesin.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take carbetapentane and guaifenesin:

• asthma, emphysema, or other breathing problems;

• heart disease or high blood pressure;

• glaucoma;

• diabetes;

• an enlarged prostate or urination problems; or

• overactive thyroid.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before taking carbetapentane and guaifenesin, tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication 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 Tusso-ZR (carbetapentane and guaifenesin)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Cold medicine is usually taken for only a short time until your symptoms clear up.

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take this medication with a full glass of water. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. You may take this medication with or without food. Taking it with food or milk may decrease stomach upset.

Measure the liquid 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.

Do not crush, chew or break an extended-release tablet. Swallow the pill whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Talk with your doctor if your symptoms do not improve after 7 days of taking this medication. Call your doctor any time if your symptoms get worse or if you also have a fever, headache, or skin rash.

This medication can cause you to have unusual results with medical tests. Tell any doctor who treats you if you have taken a cold medicine within the past few days.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medication at room temperature away from moisture, heat, and light. Do not allow liquid medicine to freeze.

What happens if I miss a dose?

Since cold or allergy medicine is often taken 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, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose can cause confusion, agitation, or restless feeling.

What should I avoid while taking Tusso-ZR (carbetapentane and guaifenesin)?

This medication can cause side effects that may cause drowsiness, dizziness, or blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Avoid drinking alcohol. It can increase some of the side effects of this medication. Do not use any other over-the-counter cough, cold, or allergy medication without first asking your doctor or pharmacist. Guaifenesin is contained in many combination medicines available over the counter. If you take certain products together you may accidentally take too much guaifenesin. Read the label of any other medicine you are using to see if it contains a guaifenesin.

Tusso-ZR (carbetapentane and guaifenesin) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• confusion, hallucinations, feeling restless or nervous;

• tremors; or

• extreme weakness.

Less serious side effects may include:

• drowsiness, dizziness;

• headache;

• sleep problems (insomnia); or

• nausea.

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 Tusso-ZR (carbetapentane and guaifenesin)?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by carbetapentane and guaifenesin.

This list is not complete and there may be other drugs that can interact with carbetapentane and guaifenesin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about carbetapentane and guaifenesin.

• 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: 1.03. Revision Date: 11/17/2009 12:46:51 PM.

Generic Name: Carbetapentane/Guaifenesin (kar-bay-ta-PEN-tane/gwye-FEN-e-sin)
Brand Name: Examples include Oratuss and Tusso-ZR

Tusso-ZR Liquid is used for:

Relieving unproductive cough and reducing mucus in the chest due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Tusso-ZR Liquid is a cough suppressant and expectorant combination. The cough suppressant works in the brain to help decrease the cough reflex. The expectorant works by thinning mucus (phlegm) in the lungs, making it less sticky and easier to cough up. This makes coughs more productive.

Do NOT use Tusso-ZR Liquid if:

• you are allergic to any ingredient in Tusso-ZR Liquid
• you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) with the last 14 days

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

Before using Tusso-ZR Liquid:

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

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have chronic cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough produces large amounts of mucus
• if you have a history of heart problems, high blood pressure, prostate problems, an overactive thyroid, diabetes, or glaucoma

Some MEDICINES MAY INTERACT with Tusso-ZR Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• MAOIs (eg, phenelzine) because they may increase the risk of Tusso-ZR Liquid’s side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tusso-ZR Liquid 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 Tusso-ZR Liquid:

Use Tusso-ZR Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Tusso-ZR Liquid by mouth with or without food.
• Drinking extra fluids while you are taking Tusso-ZR Liquid is recommended. Check with your doctor for instructions.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Tusso-ZR Liquid and you are taking it regularly, 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 Tusso-ZR Liquid.

Important safety information:

• Tusso-ZR Liquid may cause drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Tusso-ZR Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Tusso-ZR Liquid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do not use Tusso-ZR Liquid for a cough with a lot of mucous. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.
• If cough persists for more than 1 week or is accompanied by a fever, contact your health care provider. A persistent cough could be a sign of a serious condition.
• Tusso-ZR Liquid may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Tusso-ZR Liquid.
• Caution is advised when using Tusso-ZR Liquid in CHILDREN; they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tusso-ZR Liquid while you are pregnant. It is not known if Tusso-ZR Liquid is found in breast milk. If you are or will be breast-feeding while you use Tusso-ZR Liquid, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Tusso-ZR Liquid:

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:

Drowsiness; dry mouth, nose, or throat; upset stomach.

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 restlessness; seizures; severe agitation.

Proper storage of Tusso-ZR Liquid:

Store Tusso-ZR Liquid 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 Tusso-ZR Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Tusso-ZR Liquid, please talk with your doctor, pharmacist, or other health care provider.
• Tusso-ZR Liquid 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 Tusso-ZR Liquid. 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: chlorpheniramine, dextromethorphan, and phenylephrine (klor feh NEER a meen, dex troe meh THOR fan, and feh nill EH frin)
Brand Names: Alka-Seltzer Plus Cold and Cough, C-Phen DM, C-Phen DM Drops, Cardec DM, Cardec DM Drops, Ceron-DM, Ceron-DM Drops, Cerose DM, Corfen-DM, CP Dec DM, CP Dec-DM Drops, De-Chlor DM, De-Chlor DR, Dec-Chlorphen DM, Dex PC, DM-PE-Chlor, Donatussin DM Drops, Ed A-Hist DM, HistadecDM, Maxiphen ADT, Mintuss DR, nasohist-DM, Neo DM Drops, Nohist-DMX, Norel DM, P Chlor DM, PD-Cof, PD-Cof Drops, Poly-Tussin DM, Quartuss DM, Reme Tussin DM, Rondec-DM, Rondec-DM Drops, Rondex-DM, Rondex-DM Drops, Sildec-PE DM, Sildec-PE DM Drops, Tri-Vent DPC, Trital DM, Tussplex DM, Zotex-12D

What is Tussplex DM (chlorpheniramine, dextromethorphan, and phenylephrine)?

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.

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

Chlorpheniramine, dextromethorphan, and phenylephrine is used to treat sneezing, cough, runny or stuffy nose, 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 phenylephrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Tussplex DM (chlorpheniramine, dextromethorphan, and phenylephrine)?

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use 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 one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant. Chlorpheniramine, dextromethorphan, and phenylephrine 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.

What should I discuss with my healthcare provider before taking Tussplex DM (chlorpheniramine, dextromethorphan, and phenylephrine)?

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, dextromethorphan, or phenylephrine, or if you have:

• kidney disease;
• liver disease;

• diabetes;

• glaucoma;

• heart disease or high blood pressure;

• diabetes;

• a thyroid disorder;

• a stomach ulcer or a stomach obstruction,

• emphysema or chronic bronchitis; or

• an enlarged prostate or urination problems.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category C. 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 phenylephrine 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 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 Tussplex DM (chlorpheniramine, dextromethorphan, and phenylephrine)?

Use this medication exactly as directed on the label or as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor.

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take this medicine with a full glass of water. If you use the effervescent tablet, drop the tablet in 8 ounces of water and allow it to dissolve completely. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

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 where you can get one.

Take this medicine with food or milk if it upsets your stomach.

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.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

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

What happens if I miss a dose?

Since cough or 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.

Overdose symptoms 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 Tussplex DM (chlorpheniramine, dextromethorphan, and phenylephrine)?

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. Before taking this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by this medication.

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. Antihistamines, decongestants, and cough suppressants are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant.

Tussplex DM (chlorpheniramine, dextromethorphan, and phenylephrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• fast, pounding, or uneven heartbeat;

• confusion, hallucinations, unusual thoughts or behavior;

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

• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

• confusion, hallucinations;

• slow, shallow breathing;

• urinating less than usual or not at all;

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

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• blurred vision;

• dry mouth;

• nausea, stomach pain, constipation;

• mild loss of appetite, stomach upset;

• warmth, tingling, or redness under your skin;

• feeling excited or restless;

• sleep problems (insomnia);

• restless or excitability (especially in children);

• skin rash or itching;

• dizziness, drowsiness;

• problems with memory or concentration; or

• ringing in your ears.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Tussplex DM (chlorpheniramine, dextromethorphan, and phenylephrine)?

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

• an antidepressant;

• a diuretic (water pill);

• medication to treat irritable bowel syndrome;

• celecoxib (Celebrex);

• cinacalcet (Sensipar);

• imatinib (Gleevec);

• quinidine (Quinaglute, Quinidex);

• ranolazine (Ranexa)

• ritonavir (Norvir);

• sibutramine (Meridia);

• terbinafine (Lamisil);

• medicines to treat high blood pressure;

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

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

• a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others.

This list is not complete and there may be other drugs that can interact with chlorpheniramine, dextromethorphan, and phenylephrine. 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 chlorpheniramine, dextromethorphan, and phenylephrine.

• 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: 5.1. Revision Date: 4/12/2009 4:40:57 PM.

Generic Name: Guaifenesin/Hydrocodone (gwye-FEN-e-sin/hye-droe-KOE-done)
Brand Name: Tusso-HC

Tusso-HC Sustained-Release Tablets are used for:

Relieving cough and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Tusso-HC Sustained-Release Tablets are a cough suppressant and expectorant combination. It works by loosening mucus and lung secretions in the chest, and making coughs more productive. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Tusso-HC Sustained-Release Tablets if:

• you are allergic to any ingredient in Tusso-HC Sustained-Release Tablets or any other codeine or morphine-related medicine (eg, oxycodone)
• you are taking sodium oxybate (GHB)
• you have increased pressure in the brain, trouble breathing, or diarrhea due to antibiotic use

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

Before using Tusso-HC Sustained-Release Tablets:

Some medical conditions may interact with Tusso-HC Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of glaucoma, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, stroke, adrenal gland problems, or an underactive thyroid
• if you have a history of stomach problems, bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent abdominal surgery
• if you have breathing or lung problems (eg, asthma, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if cough occurs with large amounts of mucus
• if you have recently had any head injury, brain injury or tumor, infection of the brain or nervous system, epilepsy, or seizures
• if you have a history of alcohol abuse, drug abuse, or suicidal thoughts or behavior

Some MEDICINES MAY INTERACT with Tusso-HC Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Cimetidine because it may increase the risk of Tusso-HC Sustained-Release Tablets’s side effects
• Barbiturates (eg, phenobarbital) or sodium oxybate (GHB) because the risk of severe drowsiness or breathing problems may be increased
• Naltrexone because it may decrease Tusso-HC Sustained-Release Tablets’s effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tusso-HC Sustained-Release Tablets 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 Tusso-HC Sustained-Release Tablets:

Use Tusso-HC Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Tusso-HC Sustained-Release Tablets by mouth with or without food.
• Swallow Tusso-HC Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing.
• Drink plenty of water while taking Tusso-HC Sustained-Release Tablets.
• If you miss a dose of Tusso-HC Sustained-Release Tablets, 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 Tusso-HC Sustained-Release Tablets.

Important safety information:

• Tusso-HC Sustained-Release Tablets may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Tusso-HC Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• If your symptoms do not bet better within 5 to 7 days or if they get worse, check with your doctor.
• Tusso-HC Sustained-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Tusso-HC Sustained-Release Tablets.
• Tell your doctor or dentist that you take Tusso-HC Sustained-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
• Use Tusso-HC Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.
• Tusso-HC Sustained-Release Tablets should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tusso-HC Sustained-Release Tablets while you are pregnant. It is not known if Tusso-HC Sustained-Release Tablets are found in breast milk. Do not breast-feed while taking Tusso-HC Sustained-Release Tablets.

Possible side effects of Tusso-HC Sustained-Release Tablets:

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; dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; change in amount of urine; difficulty urinating; hearing change or loss; mental or mood changes; severe drowsiness.

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 Tusso-HC Sustained-Release Tablets:

Store Tusso-HC Sustained-Release Tablets 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 Tusso-HC Sustained-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Tusso-HC Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Tusso-HC Sustained-Release Tablets are 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 Tusso-HC Sustained-Release Tablets. 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.