NDC 72460-810

ColdaeWon Cough A

Acetaminophen, Ephedrine Hcl, Guaifenesin

ColdaeWon Cough A is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Daewon Pharmaceutical Co., Ltd.. The primary component is Acetaminophen; Guaifenesin; Ephedrine Hydrochloride.

Product ID72460-810_00e362fd-88e1-49c9-949b-95009ec69de2
NDC72460-810
Product TypeHuman Otc Drug
Proprietary NameColdaeWon Cough A
Generic NameAcetaminophen, Ephedrine Hcl, Guaifenesin
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2019-06-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameDaewon Pharmaceutical Co., Ltd.
Substance NameACETAMINOPHEN; GUAIFENESIN; EPHEDRINE HYDROCHLORIDE
Active Ingredient Strength300 mg/20mL; mg/20mL; mg/20mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 72460-810-01

5 POUCH in 1 CARTON (72460-810-01) > 20 mL in 1 POUCH
Marketing Start Date2019-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72460-810-01 [72460081001]

ColdaeWon Cough A SYRUP
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-01

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN300 mg/20mL

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