Label: DIPHENHYDRAMINE HYDROCHLORIDE 25MG tablet

  • NDC Code(s): 70692-148-01, 70692-148-46
  • Packager: Strive Pharmaceuticals 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 April 18, 2023

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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 and throat
    • temporarily relieves these symptoms due to the common cold:
          • runny nose             • sneezing

  • Warnings

    Do not use
    • to make a child sleepy
    • with other products containing diphenhydramine, even ones 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 & children 12 years of age and over take 1 to 2 tablets
     children 6 years of age to under 12 years of age take 1 tablet
     children under 6 years of age do not use

  • Other information

    • each tablet contains: calcium 18.64 mg
    • store at room temperature between 20 - 25°C (68-77°F).
    • avoid excessive heat, cold and humidity.
    • close cap tightly after use.

  • Inactive ingredients

    croscarmellose sodium, dicalcium phosphate, D&C red #27 aluminum lake, 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 Ultratabs®*

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

    Product of India

    Packaged & Quality Assured in USA

    REV.00-102022

    READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division., owner of the registered trademark Benadryl® Allergy Ultratabs®

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

  • Packaging

    AlergyRelief-148DrugFacts-148

  • 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
    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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