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dextromethorphan polistirex

FDA Drug Profile — Cough DM, signature care 12 hour cough relief, Signature Care Cough Relief, Good Neighbor Pharmacy Cough DM ER, Equate Cough DM

Drug Details

Generic Name
dextromethorphan polistirex
Brand Names
Cough DM, signature care 12 hour cough relief, Signature Care Cough Relief, Good Neighbor Pharmacy Cough DM ER, Equate Cough DM, DG Health Cough DM, CareOne Cough DM, foster and thrive 12 hour cough relief, basic care childrens cough dm, cough dm, Childrens Robitussin 12 Hour Cough Relief, Robitussin 12 Hour Cough Relief, dextromethorphan polistirex extended release, Good Sense Cough DM, TopCare Cough DM, CHILDRENS 12 HR COUGH RELIEF, Leader Cough DM, equaline cough dm, up and up 12 hour cough relief, Topcare Cough DM, leader childrens cough dm, basic care cough dm, good sense cough dm
Application Number
ANDA091135
Sponsor
Rite Aid Corporation
NDC Codes
50
Dosage Forms
SUSPENSION, EXTENDED RELEASE, SUSPENSION
Routes
ORAL
Active Ingredients
DEXTROMETHORPHAN HYDROBROMIDE

Indications and Usage

Uses temporarily relieves • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants • the impulse to cough to help you get to sleep

Warnings

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. Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. Ask a doctor before use if you have • chronic cough that lasts as occurs with smoking, asthma or emphysema • cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if • side effects occur. You may report side effects to FDA at 1-800-FDA-1088. • cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. 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 (1-800-222-1222).