NDC 70000-0289

Severe Cold and Flu Maximum Strength, Daytime, Non-Drowsy

Acetaminophen. Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

Severe Cold and Flu Maximum Strength, Daytime, Non-Drowsy is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Cardinal Health. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID70000-0289_104f6d4b-4609-43b1-81e1-c14327085ba3
NDC70000-0289
Product TypeHuman Otc Drug
Proprietary NameSevere Cold and Flu Maximum Strength, Daytime, Non-Drowsy
Generic NameAcetaminophen. Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-02-27
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameCardinal Health
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70000-0289-1

1 BLISTER PACK in 1 CARTON (70000-0289-1) > 12 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2014-02-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70000-0289-1 [70000028901]

Severe Cold and Flu Maximum Strength, Daytime, Non-Drowsy TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2014-02-27

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:4087e7e4-17b6-42fb-a7a9-af9ef2938f38
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1110988
  • UPC Code
  • 0096295131826

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