NDC 43913-406

G-Tuss-NL Ped

Dextromethorphan Hydrobromide, Guaifenesin, And Pseudoephedrine Hydrochloride

G-Tuss-NL Ped is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Mclaren Medical. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Pseudoephedrine Hydrochloride.

Product ID43913-406_bdcee84a-2613-400a-a813-8ba860ed66c0
NDC43913-406
Product TypeHuman Otc Drug
Proprietary NameG-Tuss-NL Ped
Generic NameDextromethorphan Hydrobromide, Guaifenesin, And Pseudoephedrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2014-02-11
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameMcLaren Medical
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength5 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 43913-406-16

473 mL in 1 BOTTLE, PLASTIC (43913-406-16)
Marketing Start Date2014-02-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43913-406-16 [43913040616]

G-Tuss-NL Ped LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-02-11
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/5mL

OpenFDA Data

SPL SET ID:0c2632f4-edbc-47d4-94ef-af3512520596
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1098911
  • NDC Crossover Matching brand name "G-Tuss-NL Ped" or generic name "Dextromethorphan Hydrobromide, Guaifenesin, And Pseudoephedrine Hydrochloride"

    NDCBrand NameGeneric Name
    43913-406G-Tuss-NL PedDextromethorphan Hydrobromide, Guaifenesin, and Pseudoephedrine Hydrochloride
    43913-404G-Tuss-NLDextromethorphan Hydrobromide, Guaifenesin, and Pseudoephedrine Hydrochloride
    43913-407G-Xpect PSEDextromethorphan Hydrobromide, Guaifenesin, and Pseudoephedrine Hydrochloride

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