NDC 52083-056

SUPRESS-PE Pediatric

Guiafenesin, Phenylephrine Hcl

SUPRESS-PE Pediatric is a Oral Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by Kramer Novis. The primary component is Guaifenesin; Phenylephrine Hydrochloride.

Product ID52083-056_6b4b229d-56e9-4920-9549-f60f50667f27
NDC52083-056
Product TypeHuman Otc Drug
Proprietary NameSUPRESS-PE Pediatric
Generic NameGuiafenesin, Phenylephrine Hcl
Dosage FormSolution/ Drops
Route of AdministrationORAL
Marketing Start Date2014-01-14
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameKramer Novis
Substance NameGUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength50 mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52083-056-01

30 mL in 1 BOTTLE, DROPPER (52083-056-01)
Marketing Start Date2014-01-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52083-056-01 [52083005601]

SUPRESS-PE Pediatric SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2014-01-14

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN50 mg/mL

OpenFDA Data

SPL SET ID:a474171d-5c29-4a80-9d37-00613796211a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 824600

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