Label: DIPHENHYDRAMINE HYDROCHLORIDE 25MG tablet

  • NDC Code(s): 70692-148-01, 70692-148-11, 70692-148-40, 70692-148-46, view more
    70692-148-62
  • Packager: Strive Pharmaceuticals Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2024

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  • Drug Facts

  • Active ingredient (in each tablet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or 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 prostate gland

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

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

  • Directions

    • take every 4 to 6 hours, or as directed by doctor
    • do not take more than 6 times in 24 hours

     adults and children 12 years and older 1 to 2 tablets
     children 6 to under 12 years 1 tablet
     children under 6 years old do not use

  • Other information

    • each tablet contains: calcium 18.64 mg
    • store between 20-25°C (68-77°F)
    • protect from light.

  • Inactive ingredients

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

  • Questions or comments?

    1-888-577-8033 Monday-Friday 8am-4pm EST

  • SPL UNCLASSIFIED SECTION

    RIGHT REMEDIES

    Compare to the active ingredient of Benadryl® Allergy ULTRATAB®*

    *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy ULTRATAB® 

    Distributed by:
    Strive Pharmaceuticals Inc.
    East Brunswick, NJ 08816

    Product of India
    Packaged and Quality Assured in the USA

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

  • Packaging

    Strive-148-1

    Strive-148-2

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 25MG 
    diphenhydramine hydrochloride 25mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-148
    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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize12mm
    FlavorImprint Code DP
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70692-148-01100 in 1 PACKAGE; Type 0: Not a Combination Product12/28/2018
    2NDC:70692-148-461 in 1 CARTON04/06/2023
    272 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:70692-148-40400 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2021
    4NDC:70692-148-62600 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2021
    5NDC:70692-148-111000 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/20/2018
    Labeler - Strive Pharmaceuticals Inc (080028013)
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