Brompheniramine, hydrocodone, and pseudoephedrine

Follow all directions on your prescription label. Hydrocodone can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Hydrocodone may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away hydrocodone is against the law.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Call 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.

Store at room temperature away from moisture and heat. Do not freeze. Keep track of the amount of medicine used from each new bottle. Hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

This medicine may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Drinking alcohol with this medicine can cause side effects.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• pounding heartbeats or fluttering in your chest;

• a light-headed feeling, like you might pass out;

• severe anxiety, confusion, fear;

• painful or difficult urination;

• little or no urinating; or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Side effects such as dry mouth, constipation, and confusion may be more likely in older adults.

Common side effects may include:

• dizziness, drowsiness, mood changes;

• feeling excited or irritable;

• problems with thinking or memory;

• flushing (warmth, redness, or tingly feeling);

• blurred vision; or

• nausea, dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Cough and Nasal Congestion:

Brompheniramine/hydrocodone/pseudoephedrine 2 mg-2.5 mg-15 mg/5 mL oral liquid:
10 mL orally every 4 to 6 hours.

Brompheniramine/hydrocodone/pseudoephedrine 3 mg-2.5 mg-15 mg/5 mL oral liquid:
5 to 10 mL orally every 4 to 6 hours not to exceed 40 mL daily.

Brompheniramine/hydrocodone/pseudoephedrine 6 mg-6 mg-45 mg/5 mL oral suspension, extended release:
5 mL orally every 12 hours not to exceed 10 mL daily.

Usual Pediatric Dose for Cough and Nasal Congestion:

Brompheniramine/hydrocodone/pseudoephedrine 2 mg-2.5 mg-15 mg/5 mL oral liquid:
6 to 11 years: 5 mL orally every 4 to 6 hours.
12 years or older: 10 mL orally every 4 to 6 hours.

Brompheniramine/hydrocodone/pseudoephedrine 3 mg-2.5 mg-15 mg/5 mL oral liquid:
2 to 5 years: 2.5 mL orally every 4 to 6 hours not to exceed 10 mL daily.
6 to 11 years: 5 mL orally every 4 to 6 hours not to exceed 20 mL daily.
12 years or older: 5 to 10 mL orally every 4 to 6 hours not to exceed 40 mL daily

Brompheniramine/hydrocodone/pseudoephedrine 6 mg-6 mg-45 mg/5 mL oral suspension, extended release:
6 to 11 years: 2.5 mL orally every 12 hours not to exceed 5 mL daily.
12 years or older: 5 mL orally every 12 hours not to exceed 10 mL daily.

Brompheniramine/hydrocodone/pseudoephedrine 2 mg-2.5 mg-15 mg/5 mL oral liquid:
10 mL orally every 4 to 6 hours.

Brompheniramine/hydrocodone/pseudoephedrine 3 mg-2.5 mg-15 mg/5 mL oral liquid:
5 to 10 mL orally every 4 to 6 hours not to exceed 40 mL daily.

Brompheniramine/hydrocodone/pseudoephedrine 6 mg-6 mg-45 mg/5 mL oral suspension, extended release:
5 mL orally every 12 hours not to exceed 10 mL daily.

Data not available