NDC 0280-1560

Alka-Seltzer Plus Severe Cold and Flu

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

Alka-Seltzer Plus Severe Cold and Flu 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 Hydrochloride; Chlorpheniramine Maleate.

Product ID0280-1560_763e8201-daae-43e8-e053-2991aa0a2379
NDC0280-1560
Product TypeHuman Otc Drug
Proprietary NameAlka-Seltzer Plus Severe Cold and Flu
Generic NameAcetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage FormTablet, Effervescent
Route of AdministrationORAL
Marketing Start Date2017-07-03
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameBayer HealthCare LLC.
Substance NameASPIRIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
Active Ingredient Strength250 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0280-1560-20

10 POUCH in 1 CARTON (0280-1560-20) > 2 TABLET, EFFERVESCENT in 1 POUCH
Marketing Start Date2017-07-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0280-1560-20 [00280156020]

Alka-Seltzer Plus Severe Cold and Flu TABLET, EFFERVESCENT
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-07-03

Drug Details

Active Ingredients

IngredientStrength
ASPIRIN250 mg/1

OpenFDA Data

SPL SET ID:531a86b3-2915-6d55-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1927026
  • 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
  • 0016500564966
  • NUI Code
  • N0000008832
  • N0000008836
  • N0000175721
  • N0000000160
  • N0000175578
  • N0000175722
  • NDC Crossover Matching brand name "Alka-Seltzer Plus Severe Cold and Flu" or generic name "Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    0280-1560Alka-Seltzer Plus Severe Cold and FluAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    0280-1212Alka-Seltzer Plus Maximum Strength Cold and CoughAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    0280-0023Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizzacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
    48201-009Calmadol PlusACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
    56062-239childrens cold and fluacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
    63868-374Childrens Multi-Symptom Cold PlusAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    0363-0034Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    11822-5047Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    15127-931Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    21130-034Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    41520-704Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    46122-310Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    55315-304Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    55910-043Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    51467-007COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
    55910-014DG Health cold multi symptomAcetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    58552-137Giltuss Childrens MultiSymptom Cold and FluAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    58552-136Giltuss MultiSymptom Cold and FluAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    48201-001Sanaflu XtraACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
    49873-114Stonaacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
    49873-113Stona-Sacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
    36800-809topcare childrens cold and fluacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride

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