NDC 53041-622

Childrens Tussnex

Acteaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

Childrens Tussnex is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Guardian Drug Company. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride; Guaifenesin.

Product ID53041-622_3a42dca8-725c-44a6-bcac-4c4da8c47446
NDC53041-622
Product TypeHuman Otc Drug
Proprietary NameChildrens Tussnex
Generic NameActeaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2012-05-05
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGuardian Drug Company
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN
Active Ingredient Strength325 mg/10mL; mg/10mL; mg/10mL; mg/10mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53041-622-03

1 BOTTLE in 1 CARTON (53041-622-03) > 118 mL in 1 BOTTLE
Marketing Start Date2012-05-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53041-622-03 [53041062203]

Childrens Tussnex LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-05-05

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/10mL

OpenFDA Data

SPL SET ID:19e9678d-ac34-4af8-a80f-d08fce0a5f0e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1593450
  • NDC Crossover Matching brand name "Childrens Tussnex" or generic name "Acteaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    53041-622Childrens TussnexActeaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    49348-080adult cold, flu and sore throatacteaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
    67091-221Childrens Multi-Symptom Cold and Fever ReliefActeaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    53041-618Tussnex FM Cold, Flu and Sore ThroatActeaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl

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