Carbetapentane/Pseudoephedrine Chewable Tablets

Carbetapentane/Pseudoephedrine Chewable Tablets are used for:

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

Carbetapentane/Pseudoephedrine Chewable Tablets are a decongestant and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Carbetapentane/Pseudoephedrine Chewable Tablets if:

• you are allergic to any ingredient in Carbetapentane/Pseudoephedrine Chewable Tablets
• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
• you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using Carbetapentane/Pseudoephedrine Chewable Tablets:

Some medical conditions may interact with Carbetapentane/Pseudoephedrine Chewable 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 adrenal gland problems (eg, adrenal gland tumor), heart problems, high blood pressure, diabetes, blood vessel problems, stroke, glaucoma, an enlarged prostate or other prostate problems, seizures, or an overactive thyroid
• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with Carbetapentane/Pseudoephedrine Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the side effects of Carbetapentane/Pseudoephedrine Chewable Tablets may be increased
• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
• Bromocriptine because the side effects may be increased by Carbetapentane/Pseudoephedrine Chewable Tablets
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because the effectiveness may be decreased by Carbetapentane/Pseudoephedrine Chewable Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Carbetapentane/Pseudoephedrine Chewable 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 Carbetapentane/Pseudoephedrine Chewable Tablets:

Use Carbetapentane/Pseudoephedrine Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Carbetapentane/Pseudoephedrine Chewable Tablets may be taken with or without food.
• Chew thoroughly before swallowing.
• If you miss a dose of Carbetapentane/Pseudoephedrine Chewable 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 Carbetapentane/Pseudoephedrine Chewable Tablets.

Important safety information:

• Carbetapentane/Pseudoephedrine Chewable Tablets may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Carbetapentane/Pseudoephedrine Chewable Tablets. Using Carbetapentane/Pseudoephedrine Chewable Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Do not take diet or appetite control medicines while you are taking Carbetapentane/Pseudoephedrine Chewable Tablets without checking with your doctor.
• Carbetapentane/Pseudoephedrine Chewable Tablets contains pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.
• Do NOT exceed the recommended dose or take Carbetapentane/Pseudoephedrine Chewable Tablets for longer than prescribed without checking with your doctor.
• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.
• Carbetapentane/Pseudoephedrine Chewable Tablets may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Carbetapentane/Pseudoephedrine Chewable Tablets. Use a sunscreen or protective clothing if you must be outside for a prolonged period.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Carbetapentane/Pseudoephedrine Chewable Tablets.
• Use Carbetapentane/Pseudoephedrine Chewable Tablets with caution in the ELDERLY because they may be more sensitive to its effects.
• Caution is advised when using Carbetapentane/Pseudoephedrine Chewable Tablets in CHILDREN because they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Carbetapentane/Pseudoephedrine Chewable Tablets, discuss with your doctor the benefits and risks of using Carbetapentane/Pseudoephedrine Chewable Tablets during pregnancy. It is unknown if Carbetapentane/Pseudoephedrine Chewable Tablets are excreted in breast milk. Do not breast-feed while taking Carbetapentane/Pseudoephedrine Chewable Tablets.

Possible side effects of Carbetapentane/Pseudoephedrine Chewable 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:

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.

Store Carbetapentane/Pseudoephedrine Chewable Tablets 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 Carbetapentane/Pseudoephedrine Chewable Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Carbetapentane/Pseudoephedrine Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Carbetapentane/Pseudoephedrine Chewable 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 Carbetapentane/Pseudoephedrine Chewable 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.