NDC 0536-1243

Children Cough and Cold

Chlorpheniramine Maleate, Dextromethorphan Hbr, Pseudoephedrine Hcl

Children Cough and Cold is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Rugby Laboratories. The primary component is Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Pseudoephedrine Hydrochloride.

Product ID0536-1243_85714345-54c0-4b11-809a-a7186bd0be89
NDC0536-1243
Product TypeHuman Otc Drug
Proprietary NameChildren Cough and Cold
Generic NameChlorpheniramine Maleate, Dextromethorphan Hbr, Pseudoephedrine Hcl
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2019-08-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameRUGBY LABORATORIES
Substance NameCHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength2 mg/10mL; mg/10mL; mg/10mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0536-1243-97

118 mL in 1 BOTTLE (0536-1243-97)
Marketing Start Date2019-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0536-1243-97 [00536124397]

Children Cough and Cold LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-08-01

Drug Details

Active Ingredients

IngredientStrength
CHLORPHENIRAMINE MALEATE2 mg/10mL

OpenFDA Data

SPL SET ID:6efe00ca-087c-44ae-843a-7db8999de066
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1117392
  • UPC Code
  • 0305361243975

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