Dexbromopheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl

FDA Drug Profile — SUPRESS A

Drug Details

Generic Name
Dexbromopheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl
Brand Names
SUPRESS A
Application Number
M012
Sponsor
Kramer Novis
NDC Codes
2
Dosage Forms
SYRUP
Routes
ORAL
Active Ingredients
DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • sneezing • itchy nose or throat • runny nose • itchy, watery eyes • nasal congestion • temporarily controls cough due to minor throat and bronchial irritation associated with inhaled irritants • temporarily restores freer breathing through nose

Warnings

Warnings Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product • do not exceed recommended dosage • excitability may occur, especially in children • may cause marked drowsiness • sedatives and tranquilizers may increase drowsiness effect Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • new symptoms occur • symptoms do not improve within 7 days or are accompanied by fever • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.