NDC 53041-616

Tussnex FM Cold and Sinus

Acteaminophen, Guaifenesin, Phenylephrine Hcl

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

Product ID53041-616_1d066711-15e9-4fc2-a241-79fcfd6d2741
NDC53041-616
Product TypeHuman Otc Drug
Proprietary NameTussnex FM Cold and Sinus
Generic NameActeaminophen, Guaifenesin, Phenylephrine Hcl
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2012-12-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGuardian Drug Company
Substance NameACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength650 mg/20mL; mg/20mL; mg/20mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53041-616-58

177 mL in 1 BOTTLE (53041-616-58)
Marketing Start Date2012-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53041-616-58 [53041061658]

Tussnex FM Cold and Sinus LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-01

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/20mL

OpenFDA Data

SPL SET ID:04c6bb6a-d2f8-4322-afba-e240e8090176
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1116568

  • © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.