NDC 70692-133

Acetaminophen Dextromethorphan HBr Guaifenesin Phenylephrine HCl

Acetaminophen Dextromethorphan Hbr Guaifenesin Phenylephrine Hcl

Acetaminophen Dextromethorphan HBr Guaifenesin Phenylephrine HCl is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Strive Pharmaceuticals Inc.. The primary component is Phenylephrine Hydrochloride; Dextromethorphan Hydrobromide; Acetaminophen; Guaifenesin.

Product ID70692-133_97a2f1a0-f0d5-5778-e053-2995a90a16d7
NDC70692-133
Product TypeHuman Otc Drug
Proprietary NameAcetaminophen Dextromethorphan HBr Guaifenesin Phenylephrine HCl
Generic NameAcetaminophen Dextromethorphan Hbr Guaifenesin Phenylephrine Hcl
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2019-07-10
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameStrive Pharmaceuticals Inc.
Substance NamePHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN
Active Ingredient Strength5 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70692-133-82

8 TABLET, COATED in 1 PACKAGE (70692-133-82)
Marketing Start Date2019-07-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70692-133-82 [70692013382]

Acetaminophen Dextromethorphan HBr Guaifenesin Phenylephrine HCl TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-07-10

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.