Carbetapentane/Carbinoxamine/Phenylephrine Drops

Generic Name: Carbetapentane/Carbinoxamine/Phenylephrine (car-beta-PEN-tane/kar-bi-NOX-a-meen/fen-ill-EF-rin)Brand Name: Aridex

Carbetapentane/Carbinoxamine/Phenylephrine Drops are used for:

Relieving symptoms (eg, sinus congestion, runny nose, sneezing, cough) due to colds, allergies, hay fever, sinus congestion, flu, bronchitis, and other respiratory illnesses. It may also be used for other conditions as determined by your doctor.

Carbetapentane/Carbinoxamine/Phenylephrine Drops are a cough suppressant, antihistamine, and decongestant combination. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant works by narrowing blood vessels and reducing swelling in the nasal passages.

Do NOT use Carbetapentane/Carbinoxamine/Phenylephrine Drops if:

• you are allergic to any ingredient in Carbetapentane/Carbinoxamine/Phenylephrine Drops
• you have severe high blood pressure, severe heart blood vessel disease, a rapid heartbeat, or severe heart problems
• you are taking sodium oxybate (GHB) or droxidopa, or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using Carbetapentane/Carbinoxamine/Phenylephrine Drops:

Some medical conditions may interact with Carbetapentane/Carbinoxamine/Phenylephrine Drops. 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 (eg, slow or irregular heartbeat); blood vessel problems; high blood pressure; diabetes; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; an overactive thyroid; trouble sleeping; or increased pressure in the eye
• 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/Carbinoxamine/Phenylephrine Drops. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Carbetapentane/Carbinoxamine/Phenylephrine Drops's side effects
• Benzodiazepines (eg, diazepam), bromocriptine, hydantoins (eg, phenytoin), or sodium oxybate (GHB) because the risk of their side effects may be increased by Carbetapentane/Carbinoxamine/Phenylephrine Drops
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Carbetapentane/Carbinoxamine/Phenylephrine Drops

This may not be a complete list of all interactions that may occur. Ask your health care provider if Carbetapentane/Carbinoxamine/Phenylephrine Drops 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/Carbinoxamine/Phenylephrine Drops:

Use Carbetapentane/Carbinoxamine/Phenylephrine Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Carbetapentane/Carbinoxamine/Phenylephrine Drops may be taken with or without food.
• Use the dropper that comes with Carbetapentane/Carbinoxamine/Phenylephrine Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Carbetapentane/Carbinoxamine/Phenylephrine Drops, 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/Carbinoxamine/Phenylephrine Drops.

Important safety information:

• Carbetapentane/Carbinoxamine/Phenylephrine Drops 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/Carbinoxamine/Phenylephrine Drops. Using Carbetapentane/Carbinoxamine/Phenylephrine Drops alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medicines that cause drowsiness (eg, sedatives, tranquilizers) while taking Carbetapentane/Carbinoxamine/Phenylephrine Drops. Carbetapentane/Carbinoxamine/Phenylephrine Drops will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Do not use Carbetapentane/Carbinoxamine/Phenylephrine Drops for persistent or chronic cough, such as a cough that occurs with smoking, asthma, or emphysema, or if the cough is accompanied by excessive mucus, unless directed by your doctor.
• Do not take diet or appetite control medicines while you are taking Carbetapentane/Carbinoxamine/Phenylephrine Drops without checking with your doctor.
• Carbetapentane/Carbinoxamine/Phenylephrine Drops contains phenylephrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains phenylephrine. If it does or if you are uncertain, contact your doctor or pharmacist.
• Do NOT exceed the recommended dose or take Carbetapentane/Carbinoxamine/Phenylephrine Drops 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/Carbinoxamine/Phenylephrine Drops may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Carbetapentane/Carbinoxamine/Phenylephrine Drops. Use a sunscreen or protective clothing if you must be outside for a prolonged period.
• If you are scheduled for allergy skin testing, do not take Carbetapentane/Carbinoxamine/Phenylephrine Drops for several days before the test because it may decrease your response to the skin tests.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Carbetapentane/Carbinoxamine/Phenylephrine Drops.
• Use Carbetapentane/Carbinoxamine/Phenylephrine Drops with caution in the ELDERLY because they may be more sensitive to its effects, especially confusion, seizures, hallucinations, or stroke.
• Caution is advised when using Carbetapentane/Carbinoxamine/Phenylephrine Drops in CHILDREN because they may be more sensitive to its effects.
• Use Carbetapentane/Carbinoxamine/Phenylephrine Drops with extreme caution in CHILDREN younger than 3 months of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not take Carbetapentane/Carbinoxamine/Phenylephrine Drops if you are pregnant. If you think you may be pregnant, contact your doctor immediately. It is unknown if Carbetapentane/Carbinoxamine/Phenylephrine Drops are excreted in breast milk. Do not breast-feed while taking Carbetapentane/Carbinoxamine/Phenylephrine Drops.

Possible side effects of Carbetapentane/Carbinoxamine/Phenylephrine Drops:

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

Dizziness; drowsiness; dry mouth; excitability; headache; loss of appetite; nausea; nervousness or anxiety; restlessness; trouble sleeping; upset stomach; vomiting; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mental or mood changes; overexcitement; pale skin; seizures; severe dizziness, lightheadedness, headache, or restlessness; tremor; vision changes.

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 confusion; difficulty urinating; fast, slow, or irregular heartbeat; flushing; increased reflexes; one-sided weakness; severe or persistent diarrhea, dizziness, headache, irritability, restlessness, or trouble sleeping; stomach cramps; tremor; vision or speech changes.

Proper storage of Carbetapentane/Carbinoxamine/Phenylephrine Drops:

Store Carbetapentane/Carbinoxamine/Phenylephrine Drops 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/Carbinoxamine/Phenylephrine Drops out of the reach of children and away from pets.

General information:

• If you have any questions about Carbetapentane/Carbinoxamine/Phenylephrine Drops, please talk with your doctor, pharmacist, or other health care provider.
• Carbetapentane/Carbinoxamine/Phenylephrine Drops 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/Carbinoxamine/Phenylephrine Drops. 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.