BROMPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE

FDA Drug Profile — Dimetapp Cold and Allergy

Drug Details

Generic Name
BROMPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE
Brand Names
Dimetapp Cold and Allergy
Application Number
M012
Sponsor
Foundation Consumer Brands
NDC Codes
1
Dosage Forms
ELIXIR
Routes
ORAL
Active Ingredients
BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses temporarily relieves: nasal congestion runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever temporarily restores freer breathing through the nose

Warnings

Warnings Do not use to sedate a child or to make a child sleepy if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland glaucoma a breathing problem such as emphysema, asthma, or chronic bronchitis Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant taking sedatives or tranquilizers When using this product 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 Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not get better within 7 days or are accompanied by fever If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.