NDC 52083-628

PECGEN PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor

Dextromethorphan Hydrobromide, Guaifenesin, Pseudoephedrine Hydrochloride

PECGEN PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Kramer Novis. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Pseudoephedrine Hydrochloride.

Product ID52083-628_a70acfaf-c6eb-4994-9cc9-e1b1a99409dc
NDC52083-628
Product TypeHuman Otc Drug
Proprietary NamePECGEN PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor
Generic NameDextromethorphan Hydrobromide, Guaifenesin, Pseudoephedrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2014-08-08
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameKramer Novis
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/5mL; mg/5mL; mg/5mL
Pharm ClassesAdrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 52083-628-16

474 mL in 1 BOTTLE (52083-628-16)
Marketing Start Date2014-08-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52083-628-16 [52083062816]

PECGEN PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2014-08-08

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL

OpenFDA Data

SPL SET ID:5682ac21-f20e-453d-a8ba-f6ad7e4f1426
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1435143
  • UPC Code
  • 0352083628160
  • NDC Crossover Matching brand name "PECGEN PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor" or generic name "Dextromethorphan Hydrobromide, Guaifenesin, Pseudoephedrine Hydrochloride"

    NDCBrand NameGeneric Name
    52083-628PECGEN PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE FlavorDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
    29978-606CAPMISTDextromethorphan Hydrobromide, Guaifenesin, Pseudoephedrine Hydrochloride
    52083-648DESGEN DM TabsDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
    58238-228TRISPEC PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE FlavorDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
    58238-230TRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE FlavorDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE

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