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BENALDRYL (AJES PHARMACEUTICALS,LLC)

Available Formats

Dosage Form Package Information Links
TABLET 1 BOTTLE, PLASTIC in 1 CARTON (42787-104-30) > 1250 mg in 1 BOTTLE, PLASTIC Label Information

Complete BENALDRYL Information

  • 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


  • INGREDIENTS AND APPEARANCE
    BENALDRYL 
    diphenhydramine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42787-104
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg  in 250 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color pink (pink) Score no score
    Shape CAPSULE Size 11mm
    Flavor Imprint Code C22
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42787-104-30 1 in 1 CARTON
    1 1250 mg in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 09/01/2012
    Labeler - AJES PHARMACEUTICALS,LLC (159945393)
    Establishment
    Name Address ID/FEI Business Operations
    AJES PHARMACEUTICALS,LLC 159945393 manufacture(42787-104) , repack(42787-104) , relabel(42787-104)