Chlophedianol HCl, Dexchlorpheniramine Maleate

FDA Drug Profile — VanaCof 2

Drug Details

Generic Name
Chlophedianol HCl, Dexchlorpheniramine Maleate
Brand Names
VanaCof 2
Application Number
M012
Sponsor
GM Pharmaceuticals, INC
NDC Codes
1
Dosage Forms
SOLUTION
Routes
ORAL
Active Ingredients
CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE

Indications and Usage

Uses ■ temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes ■ cough due to minor throat and bronchial irritation

Warnings

Warnings Ask a doctor before use if you have ■ a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema ■ a cough that occurs with too much phlegm (mucus) ■ a breathing problem such as emphysema or chronic bronchitis ■ trouble urinating due to an enlarged prostate gland ■ glaucoma Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product ■ excitability may occur, especially in children ■ may cause marked drowsiness ■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect ■ avoid alcoholic drinks ■ use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if ■ cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. ■ new symptoms occur 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.