NDC 0280-0021

Alka-Seltzer Plus Severe Cold Powerfast Fizz Night

Aspirin, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Bitartrate

Alka-Seltzer Plus Severe Cold Powerfast Fizz Night is a Oral Tablet, Effervescent in the Human Otc Drug category. It is labeled and distributed by Bayer Healthcare Llc.. The primary component is Aspirin; Dextromethorphan Hydrobromide; Phenylephrine Bitartrate; Doxylamine Succinate.

Product ID0280-0021_a37c32c1-16ce-8694-e053-2995a90a7356
NDC0280-0021
Product TypeHuman Otc Drug
Proprietary NameAlka-Seltzer Plus Severe Cold Powerfast Fizz Night
Generic NameAspirin, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Bitartrate
Dosage FormTablet, Effervescent
Route of AdministrationORAL
Marketing Start Date2020-04-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameBayer HealthCare LLC.
Substance NameASPIRIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE BITARTRATE; DOXYLAMINE SUCCINATE
Active Ingredient Strength500 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0280-0021-01

10 POUCH in 1 CARTON (0280-0021-01) > 2 TABLET, EFFERVESCENT in 1 POUCH
Marketing Start Date2020-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0280-0021-01 [00280002101]

Alka-Seltzer Plus Severe Cold Powerfast Fizz Night TABLET, EFFERVESCENT
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-04-01

Drug Details

Active Ingredients

IngredientStrength
ASPIRIN500 mg/1

OpenFDA Data

SPL SET ID:a2b30c27-b836-f09f-e053-2995a90ac383
Manufacturer
UNII
UPC Code
  • 0016500587590
  • NDC Crossover Matching brand name "Alka-Seltzer Plus Severe Cold Powerfast Fizz Night" or generic name "Aspirin, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Bitartrate"

    NDCBrand NameGeneric Name
    0280-0021Alka-Seltzer Plus Severe Cold Powerfast Fizz Nightaspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate
    0280-1545Alka-Seltzer Plus Cold NightAspirin, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine bitartrate
    0280-1541Alka-Seltzer Plus Multi-Symptom Cold NightAspirin, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine bitartrate

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