Label: DIPHENHYDRAMINE HYDROCHLORIDE 25MG tablet

  • 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 April 12, 2022

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  • ACTIVE INGREDIENT

    Diphenhydramine HCl 25mg

  • INACTIVE INGREDIENT

    colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

  • DOSAGE & ADMINISTRATION

    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 doses in 24 hours
    adults and children 12 years of age and overtake 1 to 2 caplets
    children 6 to under 12 yearstake 1 caplet
    children under 6 years of agedo not use

  • 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
  • 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 prostrate gland

    Ask a doctor or a pharmacist before use if

    you are taking sedatives or tranquilzers

    When using this product

    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and 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

    Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • PURPOSE

    Antihistamine

  • OTHER SAFETY INFORMATION

    • store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
    • avoid excessive heat, cold and humidity
  • PRINCIPAL DISPLAY PANEL

    136136-01

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 25MG 
    diphenhydramine hydrochloride 25mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-136
    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)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize12mm
    FlavorImprint Code D25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70692-136-2212 in 1 PACKAGE; Type 0: Not a Combination Product11/23/2020
    2NDC:70692-136-01100 in 1 PACKAGE; Type 0: Not a Combination Product12/28/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/20/2018
    Labeler - Strive Pharmaceuticals Inc (080028013)
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