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Pseudoephedrine/ pyrilamine/ carbetapentane liquid

Generic Name: pseudoephedrine/pyrilamine/carbetapentane (SOO-doe-e-FED-rin/pir-IL-a-meen/kar-bay-ta-PEN-tane)
Brand Name: Zotex-D

Pseudoephedrine/ pyrilamine/ carbetapentane liquid is used for:

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

Pseudoephedrine/pyrilamine/carbetapentane liquid is a decongestant, antihistamine, and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use pseudoephedrine/ pyrilamine/ carbetapentane liquid if:

  • you are allergic to any ingredient in pseudoephedrine/pyrilamine/carbetapentane liquid
  • you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, severe heart problems, stomach ulcer, or narrow-angle glaucoma
  • 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 pseudoephedrine/ pyrilamine/ carbetapentane liquid:

Some medical conditions may interact with pseudoephedrine/pyrilamine/carbetapentane 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 a fast, slow, or irregular heartbeat
  • if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems (eg, ischemic heart disease); high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; mental or mood problems (eg, depression); sleep apnea; 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
  • if you are in poor health or are very overweight

Some MEDICINES MAY INTERACT with pseudoephedrine/pyrilamine/carbetapentane liquid. 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, MAOIs (eg, phenelzine), sodium oxybate (GHB), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, potassium citrate) because they may increase the risk of pseudoephedrine/pyrilamine/carbetapentane liquid's side effects
  • Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by pseudoephedrine/pyrilamine/carbetapentane liquid
  • Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by pseudoephedrine/pyrilamine/carbetapentane liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if pseudoephedrine/pyrilamine/carbetapentane 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 pseudoephedrine/ pyrilamine/ carbetapentane liquid:

Use pseudoephedrine/pyrilamine/carbetapentane liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take pseudoephedrine/pyrilamine/carbetapentane liquid by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Take pseudoephedrine/pyrilamine/carbetapentane liquid with a full glass of water (8 oz/240 mL).
  • Drink plenty of water while taking pseudoephedrine/pyrilamine/carbetapentane liquid.
  • 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 pseudoephedrine/pyrilamine/carbetapentane liquid, 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 pseudoephedrine/pyrilamine/carbetapentane liquid.

Important safety information:

  • Pseudoephedrine/pyrilamine/carbetapentane liquid may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use pseudoephedrine/pyrilamine/carbetapentane 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 pseudoephedrine/pyrilamine/carbetapentane liquid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do not take diet or appetite control medicines while you take pseudoephedrine/pyrilamine/carbetapentane liquid without checking with your doctor.
  • Pseudoephedrine/pyrilamine/carbetapentane liquid has pseudoephedrine, pyrilamine, and carbetapentane in it. Before you start any new medicine, check the label to see if it has pseudoephedrine, pyrilamine, or carbetapentane in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Do not use pseudoephedrine/pyrilamine/carbetapentane liquid for a cough with a lot of mucus. 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 use for longer than prescribed without checking with your doctor.
  • 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.
  • Pseudoephedrine/pyrilamine/carbetapentane liquid may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to pseudoephedrine/pyrilamine/carbetapentane liquid. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Pseudoephedrine/pyrilamine/carbetapentane liquid may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking pseudoephedrine/pyrilamine/carbetapentane liquid for a few days before the tests.
  • Tell your doctor or dentist that you take pseudoephedrine/pyrilamine/carbetapentane liquid before you receive any medical or dental care, emergency care, or surgery.
  • Use pseudoephedrine/pyrilamine/carbetapentane liquid with caution in the ELDERLY; they may be more sensitive to its effects.
  • Pseudoephedrine/pyrilamine/carbetapentane liquid should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
  • Caution is advised when using pseudoephedrine/pyrilamine/carbetapentane liquid in CHILDREN; they may be more sensitive to its effects, especially excitability.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using pseudoephedrine/pyrilamine/carbetapentane liquid while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use pseudoephedrine/pyrilamine/carbetapentane liquid, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of pseudoephedrine/ pyrilamine/ carbetapentane 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:

Diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; indigestion; loss of appetite; nausea; nervousness; trouble sleeping; 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 or tightness; difficult or painful urination, inability to urinate, or changes in the amount of urine; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; increased trouble sleeping; mental or mood changes; seizures; severe dryness of mouth, nose, and throat; severe or persistent dizziness, drowsiness, lightheadedness, or headache; shortness of breath; tremor; vision changes (eg, blurred or double vision)

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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; decreased coordination or loss of balance; flushing or redness of the face; hallucinations; muscle spasms; seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe or persistent stomach cramping with nausea or vomiting; unusually fast, slow, or irregular heartbeat.

Proper storage of pseudoephedrine/pyrilamine/carbetapentane liquid:

Store pseudoephedrine/pyrilamine/carbetapentane 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 pseudoephedrine/pyrilamine/carbetapentane liquid out of the reach of children and away from pets.

General information:

  • If you have any questions about pseudoephedrine/pyrilamine/carbetapentane liquid, please talk with your doctor, pharmacist, or other health care provider.
  • Pseudoephedrine/pyrilamine/carbetapentane 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take pseudoephedrine/pyrilamine/carbetapentane liquid or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about pseudoephedrine/pyrilamine/carbetapentane liquid. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to pseudoephedrine/pyrilamine/carbetapentane liquid. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using pseudoephedrine/pyrilamine/carbetapentane liquid.

Issue Date: June 3, 2015