Label: DIPHENHYDRAMINE HYDROCHLORIDE tablet

  • NDC Code(s): 17714-023-50
  • 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 October 30, 2017

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  • Active Ingredient

    (in each TABLET)

    Diphenhydramine HCl 50 mg

  • Purpose

    Sleep Aid

  • Uses

     relieves occasional sleeplessness

  • 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

    • adults and children 12 years and over: take 1 tablet at bedtime
    • children under 12 years: ask a doctor
  • Other Information

    • store at 15-30 °C (59-86 °F)
    • protect from moisture
  • Inactive Ingredients

    Croscarmellose sodium, dicalcium phosphate, FD&C blue# 1(Al-lake), Magnesium stearate, microcrystalline cellulose.

  • Questions or Comments

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

    Manufactured by: Advance Pharmaceutical Inc. Holtsville, NY 11742

    Call 631-981-4600, 8:30 am to 4:30 pm ET, Monday-Friday

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    DIPHENHYDRAMINE HYDROCHLORIDE Tablet, USP 50 MG

    ANTIHISTAMINE

    NDC: 17714-023-50 – 50 COUNT

    Nighttime sleep 023-50

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-023
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorblue (light) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code AP;023
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17714-023-5050 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/01/2012
    Labeler - Advance Pharmaceutical Inc. (078301063)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063manufacture(17714-023)
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