NDC 62207-913

Acetaminophen Dextromethorphan Hydrobromide Doxylamine Succinate Phenylephrine Hydrochloride

Acetaminophen Dextromethorphan Hydrobromide Doxylamine Succinate Phenylephrine Hydrochloride

Acetaminophen Dextromethorphan Hydrobromide Doxylamine Succinate Phenylephrine Hydrochloride is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Granules India Limited. The primary component is Doxylamine Succinate; Dextromethorphan Hydrobromide; Acetaminophen; Phenylephrine Hydrochloride.

Product ID62207-913_50c3a7ee-04d5-363b-e054-00144ff88e88
NDC62207-913
Product TypeHuman Otc Drug
Proprietary NameAcetaminophen Dextromethorphan Hydrobromide Doxylamine Succinate Phenylephrine Hydrochloride
Generic NameAcetaminophen Dextromethorphan Hydrobromide Doxylamine Succinate Phenylephrine Hydrochloride
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2017-07-07
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGranules India Limited
Substance NameDOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength6 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 62207-913-70

8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (62207-913-70)
Marketing Start Date2017-07-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62207-913-70 [62207091370]

Acetaminophen Dextromethorphan Hydrobromide Doxylamine Succinate Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-07-07
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DOXYLAMINE SUCCINATE6.25 mg/1

OpenFDA Data

SPL SET ID:50c3a7ee-04d4-363b-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1297288

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