NDC 0280-1640

Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gels

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride

Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gels is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Bayer Healthcare Llc.. The primary component is Phenylephrine Hydrochloride; Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate.

Product ID0280-1640_6f7ba256-ed15-5fe0-e053-2a91aa0aacc1
NDC0280-1640
Product TypeHuman Otc Drug
Proprietary NameAlka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gels
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2018-07-02
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameBayer HealthCare LLC.
Substance NamePHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active Ingredient Strength5 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0280-1640-16

2 BLISTER PACK in 1 CARTON (0280-1640-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2018-07-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0280-1640-24 [00280164024]

Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gels CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-07-02

NDC 0280-1640-16 [00280164016]

Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gels CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-07-02

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:6f7ba256-ed14-5fe0-e053-2a91aa0aacc1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1297288
  • UPC Code
  • 0016500576815
  • NDC Crossover Matching brand name "Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gels" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    0280-1640Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gelsacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    0280-1580Alka-Seltzer Plus Maximum Strength Day and Night Cold and FluAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
    0280-1581Alka-Seltzer Plus Maximum Strength Day and Night Cold and FluAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
    0280-1600Alka-Seltzer Plus Maximum Strength Night Cold and FluAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
    0280-1610Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and NightAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
    0280-1620Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and CoughAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
    0280-1222Alka-Seltzer Plus Severe Sinus Congestion and Cough Liquid Gels NightAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
    0113-7501basic care nighttime cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    0113-7763basic care nigttime cold and flu severeAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
    41520-770careone allergy and cough severe sinus congestionAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
    11822-0591cold and flu reliefacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    49035-315Day and Night Cold and Flu Formulaacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    0363-1658Dye Free Cold and FluAcetaminophen, Dextromethorphan hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
    46122-272good neighbor pharmacy severe sinus congestionAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
    36800-411Night Time Cold and Flu SevereAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
    37808-606Nighttimeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    0363-5900nighttime severe cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    21130-595signature care nighttime severe cold and flu reliefacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    36800-307topcare nite time cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    36800-594topcare nite time cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    11673-763up and up nighttime severe cold and fluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
    11673-251up and up nighttime vapor ice cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.