NDC 58552-139

Giltuss Childrens Allergy Plus Cough and Congestion

Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

Giltuss Childrens Allergy Plus Cough and Congestion is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Gil Pharmaceutical Corp. The primary component is Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID58552-139_852c5a57-7ed1-3c5c-e053-2a91aa0a1433
NDC58552-139
Product TypeHuman Otc Drug
Proprietary NameGiltuss Childrens Allergy Plus Cough and Congestion
Generic NameChlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2018-11-07
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGil Pharmaceutical Corp
Substance NameCHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength2 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58552-139-04

1 BOTTLE in 1 CARTON (58552-139-04) > 118 mL in 1 BOTTLE
Marketing Start Date2018-11-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58552-139-04 [58552013904]

Giltuss Childrens Allergy Plus Cough and Congestion SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2018-11-07

Drug Details

Active Ingredients

IngredientStrength
CHLORPHENIRAMINE MALEATE2 mg/5mL

OpenFDA Data

SPL SET ID:852c5a57-7ee4-3c5c-e053-2a91aa0a1433
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1363752
  • NDC Crossover Matching brand name "Giltuss Childrens Allergy Plus Cough and Congestion" or generic name "Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    45737-250BIO-RYTUSSCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
    49963-532BronkidsChlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    52083-650GENCONTUSSCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
    58552-138Giltuss Allergy PlusCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
    58552-139Giltuss Childrens Allergy PlusCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
    76117-001RycontussCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

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