NDC 63824-793

Mucinex Fast-Max Night Time Cold and Flu

Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride

Mucinex Fast-Max Night Time Cold and Flu is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Rb Health (us) Llc. The primary component is Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride.

Product ID63824-793_047ed825-b308-4bb4-892b-d32bd9372d0d
NDC63824-793
Product TypeHuman Otc Drug
Proprietary NameMucinex Fast-Max Night Time Cold and Flu
Generic NameAcetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-09-10
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameRB Health (US) LLC
Substance NameACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1
Pharm ClassesAdrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63824-793-08

4 POUCH in 1 CARTON (63824-793-08) > 2 TABLET, FILM COATED in 1 POUCH (63824-793-02)
Marketing Start Date2018-09-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63824-793-08 [63824079308]

Mucinex Fast-Max Night Time Cold and Flu TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-09-10

NDC 63824-793-02 [63824079302]

Mucinex Fast-Max Night Time Cold and Flu TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-09-10

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:ce0c2550-39ab-4393-afb5-7d8889733768
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1233575
  • NDC Crossover Matching brand name "Mucinex Fast-Max Night Time Cold and Flu" or generic name "Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    63824-550Mucinex Fast-Max Night Time Cold and FluMucinex Fast-Max Night Time Cold and Flu
    63824-593Mucinex Fast-Max Night Time Cold and FluMucinex Fast-Max Night Time Cold and Flu
    63824-793Mucinex Fast-Max Night Time Cold and FluMucinex Fast-Max Night Time Cold and Flu
    57344-124Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine HydrochlorideAcetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
    57344-125Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine HydrochlorideAcetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
    57344-127Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine HydrochlorideACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE
    57344-155Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine HydrochlorideACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE
    57344-156Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine HydrochlorideAcetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
    57344-126Acetaminophen, Diphenhydramine Hyhrochloride, Phenylephrine HydrochlorideACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE
    15127-973Allergy and Cold PEACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE
    46122-053Allergy Plus Severe Sinus HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE
    36800-501Allergy Plus Sinus HeadacheAcetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
    46122-052Allergy Plus Sinus HeadacheAcetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
    46122-405Allergy Plus Sinus HeadacheAcetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
    61941-0301Cold-EEZEAcetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
    61941-0401Cold-EEZEAcetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
    63824-110DelsymAcetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
    63824-211DelsymAcetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
    30142-113Kroger NiteTime Flu plus Severe Cold and CoughAcetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride
    51672-2113NighttimeAcetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
    11822-2113Rite Aid Nighttime Severe Cold and Cough ReliefAcetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride
    55758-009SanaTos Severe Cold and Cough NighttimeAcetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride
    36800-500Severe Allergy Plus Sinus HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE
    50804-473Severe Allergy Relief Plus Sinus HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE
    15127-974Severe Cold PEAcetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
    36800-504Severe Cold PEAcetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
    41190-113ShopRite Nighttime Flu Plus Severe Cold and CoughAcetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride
    11673-113up and upAcetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride
    37000-926VIcks Flu Therapyacetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride
    58933-926VIcks Flu Therapyacetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride

    Trademark Results [Mucinex Fast-Max]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MUCINEX FAST-MAX
    MUCINEX FAST-MAX
    97257726 not registered Live/Pending
    RB Health (US) LLC
    2022-02-08
    MUCINEX FAST-MAX
    MUCINEX FAST-MAX
    87447620 5373718 Live/Registered
    RB HEALTH (US) LLC
    2017-05-12

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