Label: BENALDRYL- diphenhydramine hcl tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 25, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)

    Diphenhydramine HCI USP 25 mg

  • PURPOSE

    Purpose

    Antihistamine

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children

    In case of accidental overdose,

    seek professional assistance or contact a Poison Control Center

  • INDICATIONS & USAGE

    Uses

    -temporarily relieves these symptoms due to hay fever or upper

    respiratory allergies: runny nose - sneezing - itchy, watery eyes

    -itching of the nose and throat - temporarily relieves these

    symptoms due to the common cold: runny nose - sneezing

  • WARNINGS

    Warnings

    Do Not Use - to make a child sleepy - with any other product

    containing diphenhydramine, even one used on skin

  • DOSAGE & ADMINISTRATION

    Directions - take every 4 to 6 hours

    -do not take more than 6 doses in 24 hours

    adults and children 12 years of age or older - 1 to 2 tablets

    children 6 years to under 12 years of age - 1 tablet

    children under 6 years of age  -  do not use this product in children under 6 years of age

  • INACTIVE INGREDIENT

    Enter section text here

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    BENALDRYL 
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42787-104
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 250 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorpink (pink) Scoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code C22
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42787-104-121 in 1 CARTON
    125000 mg in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2012
    Labeler - AJES PHARMACEUTICALS,LLC (159945393)
    Establishment
    NameAddressID/FEIBusiness Operations
    AJES PHARMACEUTICALS,LLC159945393manufacture(42787-104) , repack(42787-104) , relabel(42787-104)
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