Label: DIPHENHYDRAMINE HYDROCHLORIDE tablet

  • NDC Code(s): 17714-135-01
  • Packager: Advance Pharmaceutical Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 22, 2017

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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
    • itchy nose or throat
    • sneezing
    • itchy, watery eyes
  • Warnings

    Do not use with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

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

      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.

  • Directions

    • take every 4-6 hours
    • do not take more than 6 doses in 24 hours
    • adults and children 12 years and over : 1-2 tablets
    • children under 12 years: ask a doctor
  • Other Information

    • each tablet contains: calcium 45 mg
    • store at 15-30 °C (59-86 °F)
    • protect from moisture
  • Inactive Ingredients

    croscarmellose sodium, D&C red# 27, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, opadry clear, titanium dioxide

  • Questions or Comments

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BOKEN OR MISSING

    Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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    DIPHENHYDRAMINE HYDROCHLORIDE TABLETx`, USP 25 MG

    ANTIHISTAMINE

    NDC: 17714-135-01 – 100 MINI TABLETS

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-135
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code AP;135
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17714-135-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/26/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/26/2006
    Labeler - Advance Pharmaceutical Inc. (078301063)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063manufacture(17714-135)
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