NDC 63824-954

Mucinex Childrens Cold and Flu

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

Mucinex Childrens Cold and Flu is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Rb Health (us) Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID63824-954_2016d378-0bf2-4f7a-8ed8-ffbf43aa01bb
NDC63824-954
Product TypeHuman Otc Drug
Proprietary NameMucinex Childrens Cold and Flu
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2019-04-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameRB Health (US) LLC
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/10mL; mg/10mL; mg/10mL; mg/10mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63824-954-04

1 BOTTLE in 1 CARTON (63824-954-04) > 118 mL in 1 BOTTLE
Marketing Start Date2019-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63824-954-04 [63824095404]

Mucinex Childrens Cold and Flu SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-04-01

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/10mL

OpenFDA Data

SPL SET ID:5bda415d-739f-4ca5-b5b2-07c14a81863b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1116572
  • NDC Crossover Matching brand name "Mucinex Childrens Cold and Flu" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    63824-954Mucinex Childrens Cold and FluMucinex Childrens Cold and Flu
    0280-0921Alka-Seltzer Plus Day Severe Cold Plus FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-502COLD AND FLU SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-986Cold and Flu Severe DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    37000-524DayQuil Severe plus Vicks VapoCoolAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
    37808-178DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-474Head Congestion plus Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-298Mucus Relief Cold and Flu All In OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-697Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-764Mucus Relief Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    37808-164Mucus Relief Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    37808-497Mucus Relief Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    37808-079Mucus Relief Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-775Pressure Plus Pain PE Plus ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    15127-184Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    37000-810Vicks DayQuilAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
    37000-811Vicks DayQuilAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
    0363-8591Walgreens Severe Cold Multi-Symptom For Adultsacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride

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