Label: APHENAP- diphenhydramine hydrochloride tablet 

  • Label RSS
  • NDC Code(s): 46084-041-11, 46084-041-12, 46084-041-13, 46084-041-14, view more
    46084-041-15, 46084-041-23
  • Packager: A P J Laboratories Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/14

If you are a consumer or patient please visit this version.

  • active ingredient

    DIPHENHYDRAMINE HYDROCHLORIDE Close
  • purpose

    Antihistamine

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  • 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). Close
  • 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

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  • 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.

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  • 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

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  • inactive ingredient

    CELLULOSE, MICROCRYSTALLINE

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  • INACTIVE INGREDIENT

    MAGNESIUM STEARATE

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  • INACTIVE INGREDIENT


    METHYLPARABEN

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  • INACTIVE INGREDIENT

    POVIDONE K30

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  • INACTIVE INGREDIENT

    SILICON DIOXIDE

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  • INACTIVE INGREDIENT

    SODIUM STARCH GLYCOLATE TYPE A POTATO

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  • INACTIVE INGREDIENT

    STARCH, CORN

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  • INACTIVE INGREDIENT

    TALC

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  • INACTIVE INGREDIENT

    TITANIUM DIOXIDE

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  • INGREDIENTS AND APPEARANCE
    APHENAP 
    diphenhydramine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:46084-041
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE 30 mg
    STARCH, CORN 15 mg
    POVIDONE K30 10 mg
    METHYLPARABEN 1 mg
    TITANIUM DIOXIDE 1 mg
    MAGNESIUM STEARATE 10 mg
    TALC 15 mg
    SODIUM STARCH GLYCOLATE TYPE A POTATO 20 mg
    SILICON DIOXIDE 1 mg
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 4mm
    Flavor Imprint Code 25mg
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46084-041-15 100 in 1 BLISTER PACK
    2 NDC:46084-041-14 60 in 1 BLISTER PACK
    3 NDC:46084-041-13 30 in 1 BLISTER PACK
    4 NDC:46084-041-12 12 in 1 BLISTER PACK
    5 NDC:46084-041-11 5 in 1 BLISTER PACK
    6 NDC:46084-041-23 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 03/01/2013
    Labeler - A P J Laboratories Limited (677378339)
    Registrant - A P J Laboratories Limited (677378339)
    Establishment
    Name Address ID/FEI Business Operations
    A P J Laboratories Limited 677378339 manufacture(46084-041)
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