Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension

Generic Name: Acetaminophen/Chlorpheniramine/Dextromethorphan (a-SEET-a-MIN-oh-fen/KLOR-fen-IR-a-meen/DEX-troe-meth-OR-fan)Brand Name: Children's Tylenol Plus Cough and Runny Nose

Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension is used for:

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

Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension is an analgesic, antihistamine, and cough suppressant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The analgesic and cough suppressant work in the brain to decrease pain and fever, and to reduce a dry or unproductive cough.

Do NOT use Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension if:

• you are allergic to any ingredient in Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension
• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
• you are unable to urinate or are having an asthma attack
• you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension:

Some medical conditions may interact with Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a fast, slow, or irregular heartbeat
• if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; blood vessel problems; stroke; glaucoma or increased eye pressure; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; an overactive thyroid; liver problems; or severe kidney problems; or if you drink 3 or more drinks with alcohol per day
• if you have a history of asthma, sleep apnea, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus
• if you smoke or have a history of addiction to alcohol

Some MEDICINES MAY INTERACT with Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Furazolidone, indomethacin, isoniazid, MAOIs (eg, phenelzine), or sodium oxybate (GHB) because they may increase the risk of Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension's side effects
• Anticoagulants (eg, warfarin) because risk of bleeding, irregular heartbeat, or heart attack may be increased
• Hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension:

Use Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension by mouth with or without food.
• Shake well before each use.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension.

Important safety information:

• Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol while you use Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension.
• Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension contains acetaminophen, chlorpheniramine, and dextromethorphan. Before you start any new medicine, check the label to see if it has any of these medicines in it. If it does or if you are not sure, check with your doctor or pharmacist.
• Do not use Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension 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.
• Do NOT take more than the recommended dose or take Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension for longer than prescribed without checking with your doctor.
• If your symptoms do not get better within 5 days or if they get worse, check with your doctor.
• If your cough or other symptoms persist for more than 1 week, come back, or if you also have fever, rash, or persistent headache, check with your doctor.
• Contact your doctor if you have a sore throat that is severe, lasts more than 2 days, or occurs with fever, rash, headache, nausea, or vomiting.
• Contact your doctor if you have a fever that gets worse or lasts for more than 3 days.
• Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension may harm your liver. Your risk may be greater if you drink alcohol while you are using Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension. Talk to your doctor before you take Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension or other fever reducers if you drink more than 3 drinks with alcohol per day.
• Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension for a few days before the tests.
• Tell your doctor or dentist that you take Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension before you receive any medical or dental care, emergency care, or surgery.
• Use Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension with caution in the ELDERLY; they may be more sensitive to its effects.
• Caution is advised when using Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension in CHILDREN; they may be more sensitive to its effects, especially excitability.
• Different brands of Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.
• Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension should not be used in CHILDREN younger than 6 years old without first checking with the child's doctor; 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 Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension while you are pregnant. It is not known if Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension is found in breast milk. Do not breast-feed while taking Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension.

Possible side effects of Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; trouble sleeping; 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); dark urine; difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; vision changes; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; confusion; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension:

Store Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension, please talk with your doctor, pharmacist, or other health care provider.
• Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Acetaminophen/Chlorpheniramine/Dextromethorphan Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.