NDC 53345-034

Maximum Strength-Cough and Chest Congestion DM

Maximum Strength-cough And Chest Congestion Dm

Maximum Strength-Cough and Chest Congestion DM is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Humanwell Puracap Pharmaceutical (wuhan) Co., Ltd.. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

Product ID53345-034_817df886-3f94-4e7f-9d41-5045e705ee0b
NDC53345-034
Product TypeHuman Otc Drug
Proprietary NameMaximum Strength-Cough and Chest Congestion DM
Generic NameMaximum Strength-cough And Chest Congestion Dm
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2015-06-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active Ingredient Strength10 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53345-034-01

1 BAG in 1 BOX (53345-034-01) > 4000 CAPSULE, LIQUID FILLED in 1 BAG
Marketing Start Date2015-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53345-034-01 [53345003401]

Maximum Strength-Cough and Chest Congestion DM CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-06-30

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1

OpenFDA Data

SPL SET ID:d1830989-fe82-4f08-8618-78979fcef568
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1111663

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