Label: DIPHENHYDRAMINE HYDROCHLORIDE tablet, coated

  • 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 17, 2018

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  • ACTIVE INGREDIENT

    Active Ingredient

    (in each caplet)

    Diphenhydramine Hcl 25 mg

  • ASK DOCTOR

    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 DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
  • DO NOT USE

    Do not use

    to make a child sleepy; with any other product containing diphenhydramine, even one used on skin.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
  • WARNINGS

    Warnings

    Do not use to make a child sleepy; Do not use with any other product containing diphenhydramine even one used on skin.

  • PREGNANCY OR BREAST FEEDING

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

    Uses: temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

    runny nose; itchy water eyes sneezing;itchy nose or throat

    Temporarily relieves these symptoms due to the common cold: runny nose; sneezing
  • WHEN USING

    When using this product

    Avoid alcoholic drinks

    marked drowsiness may occur

    Alcohol, sedatives, and tranquilizers may increase drowsiness

    Excitability may occur, especially in children

    Be careful when driving a motor vehicle or operating machinery

  • DOSAGE & ADMINISTRATION

    Directions:

    Take every 4 to 6 hours

    Do not take more than 6 doses in 24 hours

    Adults and children 12 years of age and over - 1 to 2 caplets

    Children 6 to under 12 years of age - 1 caplet

    Children under 6 years of age - Do not use this product in children under 6 years of age
  • INACTIVE INGREDIENT

    Carnauba Wax, Colloidal Silicon Dioxide, Croscarmellose Sodium, Dibasic Calcium Phosphate Dihydrate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Titanium Dioxide
  • INDICATIONS & USAGE

    Uses: Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies; runny nose, itchy watery eyes; sneezing; itchy nose or throat

    Temporarily relieves these symptoms due to the common cold: runny nose; sneezing
  • PRINCIPAL DISPLAY PANEL

    BULK LABEL IMAGEEnter section text here

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-329
    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)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize7mm
    FlavorImprint Code help
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-329-00100000 in 1 CARTON; Type 0: Not a Combination Product12/17/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/2010
    Labeler - Time-Cap Labs, Inc (037052099)
    Registrant - Time-Cap Labs, Inc (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    Time-Cap Labs, Inc037052099manufacture(49483-329)
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