DIBROMM WITH PE- brompheniramine maleate, phenylephrine hydrochloride liquid
Major Pharmaceuticals
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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In Each 5 mL teaspoonful:
Brompheniramine maleate USP 1 mg
Phenylephrine HCl USP 2.5 mg
Brompheniramine maleate....................Antihistamine
Phenylephrine HCl................................Nasal decongestant
• temporarily relieves nasal congestion due to the
common cold, hay fever or other upper
respiratory allergies, or associated with sinusitis.
• temporarily relieves these symptoms due to hay
fever (allergic rhinitis): • runny nose • sneezing
• itchy, watery eyes • itching of the nose or throat
• temporarily restores freer breathing
through the nose
Do not use
• heart disease • high blood pressure
• thyroid disease • diabetes • glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or
chronic bronchitis
• do not use more than directed
• drowsiness may occur • avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase
drowsiness • be careful when driving a motor
vehicle or operating machinery • excitability may
occur, especially in children
• you get nervous, dizzy or sleepless
• symptoms do not get better within 7 days
or are accompanied by fever
In case of accidental overdose, seek professional
assistance or contact a Poison Control Center
immediately.
do not take more than 6 doses in a 24-hour period
age dose
adults and children 12 years and over..........4 teaspoonfuls every 4-6 hours
children 6 years to under 12 years...............2 teaspoonfuls every 4-6 hours
children 4 to under 6 years...........................do not use unless directed by a doctor
children under 4 years..................................do not use
• dosage cup provided
• each teaspoon contains: sodium 2 mg
• store at 20o-25oC (68o-77oF)
• not a USP elixir
DIBROMM
WITH PE
brompheniramine maleate, phenylephrine hydrochloride liquid |
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Labeler - Major Pharmaceuticals (191427277) |
Registrant - Major Pharmaceuticals (191427277) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Major Pharmaceuticals | 191427277 | REPACK(0904-5781) |