NDC 72460-800

ColdaeWon Cold A

Acetaminophen, Chlorpheniramine Maleate, Ephedrine Hcl, Guaifenesin

ColdaeWon Cold 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; Chlorpheniramine Maleate.

Product ID72460-800_17ed8f0e-fa6e-4d2d-95b4-19ab2c81f90a
NDC72460-800
Product TypeHuman Otc Drug
Proprietary NameColdaeWon Cold A
Generic NameAcetaminophen, Chlorpheniramine Maleate, 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; CHLORPHENIRAMINE MALEATE
Active Ingredient Strength300 mg/20mL; mg/20mL; mg/20mL; mg/20mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 72460-800-01

5 POUCH in 1 CARTON (72460-800-01) > 20 mL in 1 POUCH
Marketing Start Date2019-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72460-800-01 [72460080001]

ColdaeWon Cold 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
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