NDC 0280-1555

Alka-Seltzer Plus Cold and Cough

Aspirin, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate

Alka-Seltzer Plus Cold and Cough 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; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Bitartrate.

Product ID0280-1555_75862805-2cff-fb45-e053-2991aa0a1403
NDC0280-1555
Product TypeHuman Otc Drug
Proprietary NameAlka-Seltzer Plus Cold and Cough
Generic NameAspirin, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate
Dosage FormTablet, Effervescent
Route of AdministrationORAL
Marketing Start Date2018-09-14
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameBayer HealthCare LLC.
Substance NameASPIRIN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE BITARTRATE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0280-1555-20

10 POUCH in 1 CARTON (0280-1555-20) > 2 TABLET, EFFERVESCENT in 1 POUCH
Marketing Start Date2018-09-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0280-1555-20 [00280155520]

Alka-Seltzer Plus Cold and Cough TABLET, EFFERVESCENT
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-09-14

Drug Details

Active Ingredients

IngredientStrength
ASPIRIN325 mg/1

OpenFDA Data

SPL SET ID:75862805-2cfe-fb45-e053-2991aa0a1403
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1537029
  • 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
  • 0016500564997
  • NUI Code
  • N0000008832
  • N0000008836
  • N0000175721
  • N0000000160
  • N0000175578
  • N0000175722
  • NDC Crossover Matching brand name "Alka-Seltzer Plus Cold and Cough" or generic name "Aspirin, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate"

    NDCBrand NameGeneric Name
    0280-1555Alka-Seltzer Plus Cold and CoughAspirin, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine bitartrate
    0280-0023Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizzaspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate

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