NDC 0363-9790

COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE

Acetaminophen, Guaifenesin, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride

COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Walgreens. The primary component is Acetaminophen; Guaifenesin; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID0363-9790_8c195840-7fd4-d32a-e053-2995a90a7799
NDC0363-9790
Product TypeHuman Otc Drug
Proprietary NameCOLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE
Generic NameAcetaminophen, Guaifenesin, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2019-06-24
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameWalgreens
Substance NameACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0363-9790-16

2 BLISTER PACK in 1 CARTON (0363-9790-16) > 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2019-06-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0363-9790-16 [00363979016]

COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-24

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:a1e0721d-5328-4dc9-8430-6d7afe557e60
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1656815
  • NDC Crossover Matching brand name "COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE" or generic name "Acetaminophen, Guaifenesin, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    0363-9790COLD and FLUACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    0363-9892COLD and FLUACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    55910-862COLD and FLUACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    68210-1110COLD and FLUACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    68210-4084COLD and FLUACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    0363-1171COLD, Flu and Sore ThroatACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    0363-9016COLD, Flu and Sore ThroatACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    0363-9017Maximum Strength Cold and FluACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    0363-5554Maximum Strength Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    0363-9018Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    0363-8996SEVERE DAYTIME COLD and FLUACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE

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