Label: ALLERGY RELIEF CAPLET- diphenhydramine hydrochloride tablet, film coated

  • NDC Code(s): 36800-937-01, 36800-937-40
  • Packager: TOPCO ASSOCIATES LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 1, 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 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 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 a doctor
    • do not take more than 6 times in 24 hours

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

  • Other information

    • store between 20-25°C (68-77°F)
    • avoid excessive heat, cold and humidity
    • close cap tightly after use

  • Inactive ingredients

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

  • Questions or comments:

    call 1-888-423-0139

  • SPL UNCLASSIFIED SECTION

    COMPARE TO BENADRYL® ALLERGY ULTRATAB® ACTIVE INGREDIENT*

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

    DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007
    © TOPCO STVA 1120
    topcare@topco.com    www.topcarebrand.com

    REV.00-122020

    Product of India

  • Packaging

    TOPCO-937

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF CAPLET 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-937
    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)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code S2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-937-40400 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2021
    2NDC:36800-937-011 in 1 CARTON11/09/2023
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/01/2021
    Labeler - TOPCO ASSOCIATES LLC (006935977)
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