Label: APHENAP- diphenhydramine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL

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 January 2, 2014

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  • active ingredient

    DIPHENHYDRAMINE HYDROCHLORIDE
  • purpose

    Antihistamine

  • keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center right away(1-800-222-1222).
  • uses

    Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose

  • WARNINGS

    Ask a doctor before use if you have glaucoma, a breathing problem such as emphysema or chronic bronchitis, trouble urinating due to an enlarged prostate gland.

  • directions

    Adults and children 12 years and over: take 25 to 50 mg (1 to 2 tablet) every 4 to 6 hours; not more than 12 tablets in 24 hours.

    Children 6 years to 12 years of age    : take 25 mg (1 tablet) every 4 to 6 hours; not more than 6 tablets in 24 hours.

    Children under 6 years of age    : ask a doctor

  • inactive ingredient

    CELLULOSE, MICROCRYSTALLINE

  • INACTIVE INGREDIENT

    MAGNESIUM STEARATE

  • INACTIVE INGREDIENT


    METHYLPARABEN

  • INACTIVE INGREDIENT

    POVIDONE K30

  • INACTIVE INGREDIENT

    SILICON DIOXIDE

  • INACTIVE INGREDIENT

    SODIUM STARCH GLYCOLATE TYPE A POTATO

  • INACTIVE INGREDIENT

    STARCH, CORN

  • INACTIVE INGREDIENT

    TALC

  • INACTIVE INGREDIENT

    TITANIUM DIOXIDE

  • PRINCIPAL DISPLAY PANEL

    product
  • INGREDIENTS AND APPEARANCE
    APHENAP 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46084-041
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) 30 mg
    STARCH, CORN (UNII: O8232NY3SJ) 15 mg
    POVIDONE K30 (UNII: U725QWY32X) 10 mg
    METHYLPARABEN (UNII: A2I8C7HI9T) 1 mg
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 1 mg
    MAGNESIUM STEARATE (UNII: 70097M6I30) 10 mg
    TALC (UNII: 7SEV7J4R1U) 15 mg
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) 20 mg
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 1 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code 25mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46084-041-15100 in 1 BLISTER PACK
    2NDC:46084-041-1460 in 1 BLISTER PACK
    3NDC:46084-041-1330 in 1 BLISTER PACK
    4NDC:46084-041-1212 in 1 BLISTER PACK
    5NDC:46084-041-115 in 1 BLISTER PACK
    6NDC:46084-041-23100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/2013
    Labeler - A P J Laboratories Limited (677378339)
    Registrant - A P J Laboratories Limited (677378339)
    Establishment
    NameAddressID/FEIBusiness Operations
    A P J Laboratories Limited677378339manufacture(46084-041)
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