NDC 42195-281

Pseudoephedrine HCl and Guaifenesin

Pseudoephedrine Hcl, Guaifenesin

Pseudoephedrine HCl and Guaifenesin is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Xspire Pharma, Llc. The primary component is Guaifenesin; Pseudoephedrine Hydrochloride.

Product ID42195-281_a20f3a2b-4c45-4069-8c42-77a984840a45
NDC42195-281
Product TypeHuman Otc Drug
Proprietary NamePseudoephedrine HCl and Guaifenesin
Generic NamePseudoephedrine Hcl, Guaifenesin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-10-24
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameXspire Pharma, Llc
Substance NameGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength375 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 42195-281-10

100 TABLET in 1 BOTTLE (42195-281-10)
Marketing Start Date2019-10-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42195-281-10 [42195028110]

Pseudoephedrine HCl and Guaifenesin TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-10-24

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN375 mg/1

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