Label: ALLERGY- diphenhydramine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated December 13, 2016

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  • Active Ingredient

    (in each tablet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

    • runny nose
    • itching of the nose or throat
    • sneezing
    • itchy, watery eyes

      temporarily relieves these symptoms due to the common cold:

    • runny nose
    • sneezing
  • Warnings

    Do not use

    • to make a child sleepy
    • with any other product containing diphenhydramine, even one used on skin

      Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland

      Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

      When using this product

    • you may get very drowsy
    • avoid alcoholic drinks
    • alcohol, sedatives & tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

      If pregnant or breast-feeding, ask a health professional before use.

  • 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)

  • Directions

    • take every 4 to 6 hours
    • do not take more than 6 tablets in 24 hours
      Age (Yr) Dose (tablets)
      Adults and children 12 years of age and overTake 1 to 2 tablets
      Children 6 to under 12 years of ageTake 1 tablet
      Children under 6 years of agedo not use
  • Other Information

    • store at 25°C(77 °F) excusrsions permitted between 15°-30°C (59°-86°F)
    • protect from light and moisture
    • metal content: each tablet contains: Calcium 23mg, Magnesium: 0.2 mg, sodium 0.5 mg
  • Inactive Ingredients

    Carnauba Wax, Colloidal silion dioxide, croscarmellose sodium, D&C red #27 al lake, dibasic calcium phosphate dihydrate, hypromellose, Lecithin,  magnesium stearate, microcrystalline cellulose, polyethylene glycol, Polyvinyl Alcohol, polysorbate, Povidone, Purified water, starch, sodium benozoate, talc,Titanium Dioxide

  • Questions or Comments

    Call 1-855-314-1850

    READ AND KEEP CARTON FOR COMPLETE WARNING AND INFORMATION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    e1070c0c-figure-01
    e1070c0c-figure-02

    NDC 62011-0316-1

  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0316
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code EL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62011-0316-1100 in 1 BOTTLE11/25/2016
    11 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/25/2016
    Labeler - Mckesson (177667227)
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