Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride

Product NDC
35916-0167
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
SOFTGEL HEALTHCARE PRIVATE LIMITED
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
35916-0167-12 BLISTER PACK in 1 CARTON (35916-0167-1) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2024-08-22NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Acetaminophen 325 mg , Dextromethorphan Hydrobromide 10 mg, Doxylamine Succinate 6.25 mg and Phenylephrine Hydrochloride 5 mg (Night Time Severe)SOFTGEL HEALTHCARE PRIVATE LIMITED2026-01-28HUMAN OTC DRUG LABEL3