BROMPHENIRAMINE MALEATE and Phenylephrine HCL

FDA Drug Profile — RYNEX PE

Drug Details

Generic Name
BROMPHENIRAMINE MALEATE and Phenylephrine HCL
Brand Names
RYNEX PE
Application Number
M012
Sponsor
EDWARDS PHARMACEUTICALS, INC.
NDC Codes
1
Dosage Forms
LIQUID
Routes
ORAL
Active Ingredients
BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passage

Warnings

Warnings Do not exceed recommended dosage. Do not take this product if you are now taking a prescription monoamine oxidase inhibitor (MA0I) (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 a breathing problem such as emphysema or chronic bronchitis glaucoma heart disease high blood pressure thyroid disease diabetes mellitus difficulty in urination due to enlargement of the prostate gland Ask a doctor before use if you are taking sedatives or tranquilizers. When using this product excitability may occur, especially in children may cause drowsiness sedalives and tranquilizers may increase drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery Stop use and ask doctor if nervousness, dizziness, or sleeplessness occur If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor new symptoms occur If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.