NDC 0031-8750

Robitussin Maximum Strength Severe Cough Plus Sore Throat

Acetaminophen, Dextromethorphan Hydrobromide

Robitussin Maximum Strength Severe Cough Plus Sore Throat is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Richmond Division Of Wyeth. The primary component is Acetaminophen; Dextromethorphan Hydrobromide.

Product ID0031-8750_a4d2a12b-add6-46ad-bea2-1db943e232c3
NDC0031-8750
Product TypeHuman Otc Drug
Proprietary NameRobitussin Maximum Strength Severe Cough Plus Sore Throat
Generic NameAcetaminophen, Dextromethorphan Hydrobromide
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2017-04-10
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameRichmond Division of Wyeth
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength650 mg/20mL; mg/20mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0031-8750-12

1 BOTTLE in 1 CARTON (0031-8750-12) > 118 mL in 1 BOTTLE
Marketing Start Date2017-04-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0031-8750-18 [00031875018]

Robitussin Maximum Strength Severe Cough Plus Sore Throat LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-04-10

NDC 0031-8750-12 [00031875012]

Robitussin Maximum Strength Severe Cough Plus Sore Throat LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2017-04-10

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/20mL

OpenFDA Data

SPL SET ID:6a6f5da8-6433-4284-8df7-2d5b099b74dc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1919076
  • 1919082
  • NDC Crossover Matching brand name "Robitussin Maximum Strength Severe Cough Plus Sore Throat" or generic name "Acetaminophen, Dextromethorphan Hydrobromide"

    NDCBrand NameGeneric Name
    0031-8750Robitussin Maximum Strength Severe Cough Plus Sore Throatacetaminophen, dextromethorphan hydrobromide
    0113-7101Basic Care childrens cold and cough and sore throatacetaminophen, dextromethorphan hydrobromide
    69842-622childrens cough and sore throatacetaminophen, dextromethorphan Hydrobromide
    11822-2023childrens pain relief cold and cough and sore throatacetaminophen, dextromethorphan hydrobromide
    11523-0093Coricidin HBP Maximum Strength Cold, Cough and Fluacetaminophen, dextromethorphan hydrobromide
    0363-0029Cough and Sore ThroatAcetaminophen, Dextromethorphan hydrobromide
    36800-893Topcare childrens cold cough and sore throatacetaminophen, dextromethorphan Hydrobromide
    37000-027Vicks DayQuilAcetaminophen, Dextromethorphan Hydrobromide

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