Label: DIPHENHYDRAMINE HCL tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 8, 2024

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  • ACTIVE INGREDIENT

    Diphenhydramine HCl 25 mg

  • PURPOSE

    Antihistamine

  • WHEN USING

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

  • ASK DOCTOR

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

  • ASK DOCTOR/PHARMACIST

    taking sedatives or tranquilizers

  • PREGNANCY 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)

  • QUESTIONS

    609-642-6380

  • INACTIVE INGREDIENT

    Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Red No. 3, magnesium stearate, microcrystalline cellulose, polyethylene glycol, hydroxy propyl methyl cellulose talc, titanium dioxide

  • DOSAGE & ADMINISTRATION

    take every 4 to 6 hours do not take more than 6 doses in 24 hours

    adults & children 12 years & over 1 to 2 tablets
    children 6 to under 12 years 1 tablet
    children under 6 years do not use this product in children under 6 years of age

  • WARNINGS

    Do not use

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

  • INDICATIONS & USAGE

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    runny nose
    sneezing
    itchy, watery eyes
    itching of the nose or throat
    temporarily relieves these symptoms due to the common cold:
    runny nose
    sneezing

  • PRINCIPAL DISPLAY PANEL

    Main label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73376-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code I3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73376-003-801000 mg in 1 BOTTLE; Type 0: Not a Combination Product07/28/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/28/2022
    Labeler - INVAHEALTH INC (116840615)
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