NDC 49580-0297

Childrens Plus Cough and Runny Nose

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide

Childrens Plus Cough and Runny Nose is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by P & L Development, Llc. The primary component is Acetaminophen; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide.

Product ID49580-0297_4a1132b7-def6-4d46-b1a9-fd65138826d6
NDC49580-0297
Product TypeHuman Otc Drug
Proprietary NameChildrens Plus Cough and Runny Nose
Generic NameAcetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2015-06-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameP & L Development, LLC
Substance NameACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength160 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 49580-0297-4

1 BOTTLE, PLASTIC in 1 BOX (49580-0297-4) > 118 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2015-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49580-0297-4 [49580029704]

Childrens Plus Cough and Runny Nose SUSPENSION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-06-30

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN160 mg/5mL

OpenFDA Data

SPL SET ID:892073c3-1ca2-40f5-9ce6-ec87fd926065
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1086750
  • NDC Crossover Matching brand name "Childrens Plus Cough and Runny Nose" or generic name "Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide"

    NDCBrand NameGeneric Name
    0363-0297Childrens Plus Cough and Runny NoseAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide
    15127-950Childrens Plus Cough and Runny NoseAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide
    41520-297Childrens Plus Cough and Runny NoseAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide
    49580-0297Childrens Plus Cough and Runny NoseAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide
    55315-297Childrens Plus Cough and Runny NoseAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide
    55910-297Childrens Plus Cough and Runny NoseAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide
    55910-298Childrens Plus Cough and Runny NoseAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide
    63941-297Childrens Plus Cough and Runny NoseAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide
    68016-130Childrens Plus Cough and Runny NoseAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide
    11822-1434Childrens Plus Multi-Symptom Cold GrapeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
    11523-4363Coricidin HBP Maximum Strength FluAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide
    11523-0038Coricidin HBP Maximum Strength Multi Symptom FluAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide
    36800-297Cough and Runny NoseAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide
    49873-108Stona for Childrenacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide

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