Label: ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE tablet

  • NDC Code(s): 57631-010-00
  • Packager: InvaTech Pharma Solutions LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 2, 2025

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE REACH OF CHILDREN

  • INDICATIONS & USAGE

    Analgesic and Antipyretic 

  • DOSAGE & ADMINISTRATION

    FOR MANUFACTURING, PROCESSING OR REPACKING

  • WARNINGS

    KEEP OUT OF THE REACH OF CHILDREN,REMOVE SILICA GEL BAG BEFORE USE

  • INACTIVE INGREDIENT

    Microcrystalline Cellulose, Polyethylene glycol, Polyvinyl pyrrolidinone, Pregelatinized Starch, Starch, Stearic Acid powder, colloidal Silicon Dioxide, talc, Hypromellose

  • PURPOSE

    FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE 
    acetaminophen and diphenhydramine citrate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57631-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE38 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code S26
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57631-010-0030000 in 1 BOX; Type 0: Not a Combination Product10/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/01/2025
    Labeler - InvaTech Pharma Solutions LLC (078602180)
    Registrant - Elysium Pharmaceutical Ltd (915664486)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceutical Ltd915664486analysis(57631-010) , manufacture(57631-010)
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