chlorpheniramine maleate, dextrometrorphan HBr

FDA Drug Profile — Childrens Cough and Cold, CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING, CVS childrens Cough and Cold

Drug Details

Generic Name
chlorpheniramine maleate, dextrometrorphan HBr
Brand Names
Childrens Cough and Cold, CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING, CVS childrens Cough and Cold
Application Number
M012
Sponsor
FAMILY DOLLAR SERVICES INC
NDC Codes
3
Dosage Forms
LIQUID
Routes
ORAL
Active Ingredients
CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE

Indications and Usage

Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

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 trouble urinating due to an enlarged prostate gland glaucoma a 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 you are taking sedatives or tranquilizers When using this product do not use more than directed marked drowsiness may occur avoid alcoholic drinks 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 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 overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Directions measure only with dosing cup provided keep dosing cup with product mL = milliliter do not take more than 4 doses in any 24-hour period age dose Children under 6 years do not use children 6 to under 12 years 10 mL every 6 hours adults and children 12 years and older 20 mL every 6 hours Other information each 10 mL contains: sodium 7 mg store at room temperature, Do not refrigerate.