Pseudoephedrine and triprolidine

Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate.

Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or a thyroid disorder.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

• a blockage in your digestive tract (stomach or intestines), a colostomy or ileostomy;

• diabetes;

• liver or kidney disease;

• epilepsy or other seizure disorder;

• cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;

• enlarged prostate or urination problems;

• pheochromocytoma (an adrenal gland tumor); or

• if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

FDA pregnancy category C. It is not known whether pseudoephedrine and triprolidine will harm an unborn baby. Do not use this medicine without medical advice if you are pregnant.

Pseudoephedrine and triprolidine may pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use this medicine without medical advice if you are breast-feeding a baby.

Artificially sweetened cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.

Measure liquid medicine with a special dose-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.

Do not take for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

Do not give this medication to a child younger than 4 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 crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat. Do not allow the liquid form of this medicine to freeze.

Since this medicine is taken when 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. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Usual Adult Dose for Allergic Rhinitis:

Tablets:
Pseudoephedrine-triprolidine 60 mg-2.5 mg
1 tablet orally every 4-6 hours; do not exceed 4 doses in 24 hours.

Syrup:
Pseudoephedrine-triprolidine 30 mg-1.25 mg/mL oral liquid
10 mL orally every 4-6 hours; do not exceed 4 doses in 24 hours.

Liquid:
Pseudoephedrine-triprolidine 10 mg-0.938 mg/mL oral liquid:
2.67 mL orally every 6 hours. Do not take more than 4 doses in 24 hours.
Pseudoephedrine-triprolidine 45 mg-2.5 mg/5 mL oral liquid:
5 to 10 mL orally every 4 to 6 hours. (maximum pseudoephedrine: 240 mg/24 hours).

Usual Adult Dose for Cold Symptoms:

Tablets:
Pseudoephedrine-triprolidine 60 mg-2.5 mg
1 tablet orally every 4-6 hours; do not exceed 4 doses in 24 hours.

Syrup:
Pseudoephedrine-triprolidine 30 mg-1.25 mg/mL oral liquid
10 mL orally every 4-6 hours; do not exceed 4 doses in 24 hours.

Liquid:
Pseudoephedrine-triprolidine 10 mg-0.938 mg/mL oral liquid:
2.67 mL orally every 6 hours. Do not take more than 4 doses in 24 hours.
Pseudoephedrine-triprolidine 45 mg-2.5 mg/5 mL oral liquid:
5 to 10 mL orally every 4 to 6 hours. (maximum pseudoephedrine: 240 mg/24 hours).

Usual Pediatric Dose for Allergic Rhinitis:

Tablets:
Pseudoephedrine-triprolidine 60 mg - 2.5 mg.
6 years to 12 years: 1/2 tablet orally every 4-6 hours; do not exceed 4 doses in 24 hours.
13 years or older: 1 tablet orally every 4-6 hours; do not exceed 4 doses in 24 hours.

Syrup:
Pseudoephedrine-triprolidine 30 mg - 1.25 mg.
6 years to 12 years: 5 mL orally every 4-6 hours; do not exceed 4 doses in 24 hours.
13 years or older: 10 mL orally every 4-6 hours; do not exceed 4 doses in 24 hours.

Liquid:
Pseudoephedrine-triprolidine 10 mg-0.938 mg/mL oral liquid:
6 years to 11 years: 1.33 mL orally every 6 hours. Do not take more than 4 doses in 24 hours.
12 years or older: 2.67 mL orally every 6 hours. Do not take more than 4 doses in 24 hours.
Pseudoephedrine-triprolidine 45 mg-2.5 mg/5 mL oral liquid:
6 years to 11 years: 2.5 to 5 mL orally every 4 to 6 hours. (maximum pseudoephedrine: 120 mg/24 hours).
12 years or older: 5 to 10 mL orally every 4 to 6 hours. (maximum pseudoephedrine: 240 mg/24 hours).

Usual Pediatric Dose for Cold Symptoms:

Tablets:
Pseudoephedrine-triprolidine 60 mg - 2.5 mg.
6 years to 12 years: 1/2 tablet orally every 4-6 hours; do not exceed 4 doses in 24 hours.
13 years or older: 1 tablet orally every 4-6 hours; do not exceed 4 doses in 24 hours.

Syrup:
Pseudoephedrine-triprolidine 30 mg - 1.25 mg.
6 years to 12 years: 5 mL orally every 4-6 hours; do not exceed 4 doses in 24 hours.
13 years or older: 10 mL orally every 4-6 hours; do not exceed 4 doses in 24 hours.

Liquid:
Pseudoephedrine-triprolidine 10 mg-0.938 mg/mL oral liquid:
6 years to 11 years: 1.33 mL orally every 6 hours. Do not take more than 4 doses in 24 hours.
12 years or older: 2.67 mL orally every 6 hours. Do not take more than 4 doses in 24 hours.
Pseudoephedrine-triprolidine 45 mg-2.5 mg/5 mL oral liquid:
6 years to 11 years: 2.5 to 5 mL orally every 4 to 6 hours. (maximum pseudoephedrine: 120 mg/24 hours).
12 years or older: 5 to 10 mL orally every 4 to 6 hours. (maximum pseudoephedrine: 240 mg/24 hours).

Ask a doctor or pharmacist before using this medicine if you regularly use other medicines that make you sleepy (such as narcotic pain medication, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by triprolidine.

Ask a doctor or pharmacist if it is safe for you to take pseudoephedrine and triprolidine if you are also using any of the following drugs:

• atropine (Atreza, Sal-Tropine);

• benztropine (Cogentin);

• topiramate (Topamax);

• zonisamide (Zonegran);

• anti-nausea medications such as belladonna (Donnatal), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm Scop);

• bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), solifenacin (Vesicare), tolterodine (Detrol), or Urogesic Blue;

• bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

• irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or

• ulcer medicine such as glycopyrrolate (Robinul) or mepenzolate (Cantil).

This list is not complete and other drugs may interact with pseudoephedrine and triprolidine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Trouble passing urine.
• A fast heartbeat.
• A heartbeat that does not feel normal.
• Very bad dizziness or passing out.
• Shortness of breath.
• Shakiness.
• Seizures.
• Blurred eyesight.