NDC 0280-1541

Alka-Seltzer Plus Multi-Symptom Cold Night

Aspirin, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Bitartrate

Alka-Seltzer Plus Multi-Symptom Cold 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; Doxylamine Succinate; Dextromethorphan Hydrobromide; Phenylephrine Bitartrate.

Product ID0280-1541_77cfe122-d13d-06f5-e053-2991aa0a5f94
NDC0280-1541
Product TypeHuman Otc Drug
Proprietary NameAlka-Seltzer Plus Multi-Symptom Cold Night
Generic NameAspirin, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Bitartrate
Dosage FormTablet, Effervescent
Route of AdministrationORAL
Marketing Start Date2017-07-15
Marketing End Date2020-07-31
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameBayer HealthCare LLC.
Substance NameASPIRIN; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE BITARTRATE
Active Ingredient Strength500 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN

Packaging

NDC 0280-1541-20

10 POUCH in 1 CARTON (0280-1541-20) > 2 TABLET, EFFERVESCENT in 1 POUCH
Marketing Start Date2017-07-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0280-1541-20 [00280154120]

Alka-Seltzer Plus Multi-Symptom Cold Night TABLET, EFFERVESCENT
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-07-15
Marketing End Date2020-07-31

Drug Details

Active Ingredients

IngredientStrength
ASPIRIN500 mg/1

OpenFDA Data

SPL SET ID:540f375c-99e6-4444-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1536503
  • Pharm Class PE
  • Decreased Prostaglandin Production [PE]
  • Decreased Platelet Aggregation [PE]
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • Platelet Aggregation Inhibitor [EPC]
  • UPC Code
  • 0016500565000
  • NUI Code
  • N0000008832
  • N0000008836
  • N0000175721
  • N0000000160
  • N0000175578
  • N0000175722
  • NDC Crossover Matching brand name "Alka-Seltzer Plus Multi-Symptom Cold Night" or generic name "Aspirin, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Bitartrate"

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

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