Phenylephrine HCl and Chlorpheniramine maleate

FDA Drug Profile — Cold and Allergy

Drug Details

Generic Name
Phenylephrine HCl and Chlorpheniramine maleate
Brand Names
Cold and Allergy
Application Number
M012
Sponsor
Allegiant Health
NDC Codes
1
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses Uses temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • nasal congestion • itching of the nose or throat • sinus congestion and pressure

Warnings

Do not use 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 • a breathing problem such as emphysema or chronic bronchitis • glaucoma Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product • do not exceed recommended dose • excitability may occur, especially in children • drowsiness may occur • alcohol, sedatives, and tranquilizers may increase drowsiness • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occurs • symptoms do not improve within 7 days or occur with a fever. If pregnant or breast-feeding , ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).