Bromaline

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Applies to brompheniramine / pseudoephedrine: oral capsule, oral elixir, oral liquid

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.
• Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Brompheniramine Maleate 12 mg and pseudoephedrine HCL 120 mg extended release capsule: 1 capsule orally every 12 hours as needed.

Brompheniramine Maleate 6 mg and pseudoephedrine HCL 60 mg extended release capsule: 1 to 2 capsules orally every 12 hours as needed.

Brompheniramine Maleate 4 mg and pseudoephedrine HCL 60 mg immediate release tablets: 1 tablet orally every 4 hours as needed. Not to exceed 6 doses/day.

Brompheniramine Maleate 1 mg and pseudoephedrine HCL 15 mg/ 5 mL oral liquid:
20 mL orally every 4 hours as needed.

Brompheniramine Maleate 9 mg and pseudoephedrine HCL 90 mg extended release capsule: 1 capsule orally every 12 hours as needed.

Brompheniramine Maleate and pseudoephedrine HCL one 10 mg-120 mg extended release capsule orally every 12 hours as needed

Brompheniramine Maleate 12 mg and pseudoephedrine HCL 90 mg: one or two extended release capsules orally every 24 hours as needed.

Brompheniramine Tannate 8 mg and pseudoephedrine tannate 90 mg/5 mL extended release suspension: 5 mL orally every 12 hours as needed.

Brompheniramine-pseudoephedrine 6 mg-30 mg/5 mL extended release suspension 5 to 20 mL orally every 12 hours as needed. Not to exceed 40 mL in 24 hours.

Brompheniramine Maleate 4 mg and pseudoephedrine HCL 40 mg immediate release tablets: 1 tablet orally every 4 to 6 hours as needed. Not to exceed 6 doses/day.

Brompheniramine-pseudoephedrine 4 mg-20 mg/ 5 mL oral liquid 5 to 10 mL orally every 4 to 6 hours as needed (not to exceed 40 mL in 24 hours).

Brompheniramine-pseudoephedrine 10 mg-120 mg oral tablet, extended release: 1 tablet orally every 12 hours as needed.

Brompheniramine-pseudoephedrine one 4 mg-60 mg capsule orally every 4 to 6 hours as needed (not to exceed 4 capsules in 24 hours).

Alternate dosing based on the pseudoephedrine component:
30 to 60 mg orally every 6 hours. Maximum dose: 240 mg/day.

Brompheniramine Maleate 4 mg and pseudoephedrine HCL 60 mg immediate release tablets:
6 years to 12 years: 1/2 tablet orally every 4 hours as needed. Do not exceed 6 doses/day.
13 years to 18 years: 1 tablet orally every 4 hours as needed. Do not exceed 6 doses/day.

Brompheniramine Maleate 1 mg and pseudoephedrine HCL 15 mg/ 5 mL oral liquid:
6 years to 11 years: 10 mL orally every 6 hours as needed (maximum: 40 mL/24 hours).
12 years or older: 20 mL orally every 6 hours as needed (maximum: 80 mL/24 hours).

Brompheniramine Maleate 6 mg and pseudoephedrine HCL 60 mg extended release capsule:
6 years to 12 years: 1 capsule orally every 12 hours as needed.
13 years to 18 years: 1 to 2 capsules orally every 12 hours as needed.

Brompheniramine Maleate 9 mg and pseudoephedrine HCL 90 mg extended release capsule:
6 years to 11 years: 1 capsule daily as needed.
12 years or older: 1 capsule orally every 12 hours as needed.

Brompheniramine Maleate 10 mg and pseudoephedrine HCL 120 mg:
12 years or older: one extended release capsule orally every 12 hours as needed.

Brompheniramine Maleate 12 mg and pseudoephedrine HCL 90 mg extended release capsule:
6 years to 11 years: 1 capsule orally daily as needed.
12 years or older: one or two extended release capsules orally every 24 hours as needed.

Brompheniramine Tannate 8 mg and pseudoephedrine tannate 90 mg/5 mL extended release suspension: 5 mL orally every 12 hours as needed.
2 years to 5 years: 1.25 mL orally every 12 hours. Maximum dose: 2.5 mL/day.
6 years to 11 years: 2.5 mL orally every 12 hours. Maximum dose: 5 mL/day.
12 years or older: 5 mL orally every 12 hours. Maximum dose: 10 mL/day.

Brompheniramine-pseudoephedrine 6 mg-30 mg/5 mL extended release suspension 5 to 20 mL orally every 12 hours as needed
6 years to 11 years: 5 to 10 mL orally every 12 hours. Maximum dose: 20 mL/day.
12 years or older: 5 to 20 mL orally every 12 hours. Maximum dose: 40 mL/day.

Brompheniramine Maleate 4 mg and pseudoephedrine HCL 40 mg immediate release tablets:
12 years or older: 1/2 tablet orally every 4 to 6 hours as needed. Not to exceed 3 tablets/day.

brompheniramine-pseudoephedrine 4 mg-20 mg/ 5 mL oral liquid:
2 years to 5 years: 2.5 mL orally every 4 to 6 hours as needed (not to exceed 10 mL in 24 hours)
6 years to 11 years: 5 mL orally every 4 to 6 hours as needed (not to exceed 20 mL in 24 hours)
12 years or older: 5 to 10 mL orally every 4 to 6 hours as needed (not to exceed 40 mL in 24 hours)

Brompheniramine-pseudoephedrine 10 mg-120 mg oral tablet, extended release:
12 years or older: 1 tablet orally every 12 hours as needed

Brompheniramine-pseudoephedrine one 4 mg-60 mg oral capsule:
12 years or older: 1 capsule orally every 4 to 6 hours as needed (not to exceed 4 capsules in 24 hours).

Alternate dosing based on the pseudoephedrine component:
2 years to 5 years: 15 mg orally every 6 hours. Maximum dose: 60 mg/day.
6 years to 12 years: 30 mg orally every 6 hours. Maximum dose: 120 mg/day.
13 years or older: 30 to 60 mg orally every 6 hours. Maximum dose: 240 mg/day.

Alternative pediatric dosing: May dose according to the pseudoephedrine component:
Children less than 4 years: 1 mg/kg/dose every 6 hours; maximum single dose: 15 mg
Children 4 to 5 years: 1 mg/kg/dose every 6 hours; maximum single dose: 15 mg
Children 6 to 12 years: 30 mg every 4 to 6 hours; maximum dose: 120 mg/24 hours
Children over 12 years: 30 to 60 mg every 6 hours or extended release product 120 mg every 12 hours; maximum dose: 240 mg/24 hours

Caution should be exercised in patients with high blood pressure, heart disease, diabetes, thyroid disease, increased intraocular pressure, and prostatic hypertrophy.

Brompheniramine may have additive effects with other CNS depressants, including alcohol.

Antihistamines may cause excitability, especially in children.

The FDA has not approved use of over-the-counter cough and cold medications to children aged less than 2 years, and proper dosing for children in this age group has not been studied. Clinicians should be aware of the risk for serious illness or fatal overdose from administration of cough and cold medications to children aged less than 2 years. Clinicians should be certain that caregivers understand 1) the importance of administering cough and cold medications only as directed and 2) the risk for overdose if they administer additional medications that might contain the same ingredient.

Data not available

Brompheniramine-pseudoephedrine is excreted into human milk. Because of the higher than usual risk for infants from sympathomimetic amines, use of this product by nursing mothers is contraindicated.