NDC 58552-327

EXACTUSS TOTAL RELEASE

Guaifenesin, Dextromethorphan Hbr, And Phenylephrine Hcl

EXACTUSS TOTAL RELEASE is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Gil Pharmaceutical Corp. The primary component is Phenylephrine Hydrochloride; Guaifenesin; Dextromethorphan Hydrobromide.

Product ID58552-327_c9d5b39b-b35a-3d82-e053-2995a90adb5f
NDC58552-327
Product TypeHuman Otc Drug
Proprietary NameEXACTUSS TOTAL RELEASE
Generic NameGuaifenesin, Dextromethorphan Hbr, And Phenylephrine Hcl
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-10-19
Marketing CategoryOTC MONOGRAPH FINAL /
Application Numberpart341
Labeler NameGil Pharmaceutical Corp
Substance NamePHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength10 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 58552-327-01

100 TABLET, FILM COATED in 1 BOTTLE (58552-327-01)
Marketing Start Date2011-05-27
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "EXACTUSS TOTAL RELEASE" or generic name "Guaifenesin, Dextromethorphan Hbr, And Phenylephrine Hcl"

NDCBrand NameGeneric Name
58552-327EXACTUSS TOTAL RELEASEGuaifenesin, Dextromethorphan HBr, and Phenylephrine HCl
58552-317GILTUSS TOTAL RELEASEGuaifenesin, Dextromethorphan HBr, and Phenylephrine HCl

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