Label: ALLERGY RELIEF- diphenhydramine hydrochloride tablet

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

Drug Label Information

Updated March 10, 2025

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  • Active ingredient (in each caplet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:  

         o runny nose

         o sneezing

         o itchy, watery eyes

         o itchy nose or throat

    • temporarily relieves these symptoms of the common cold:

        o runny nose
        o 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

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

    Ask your doctor or pharmacist before use if youaretaking sedatives or tranquilizers

    When using this product

    • marked drowsiness may occur
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • avoid alcoholic beverages
    • 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.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • take every 4 to 6 hours, or as directed by a doctor
    • do not take not more than 6 times in 24 hours
    • adults and children 12 years  and over: 1 or 2 tablets
    • children 6 to under 12 years: 1 tablet
    • children under 6 years: do not use
  • Other Information

    • each tablet contains:calcium 30 mg
    • each tablet contains:phosphorus 15 mg
    • protect from moisture
    • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
    • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.
  • Inactive Ingredients

    Colloidal silicon dioxide, Croscarmellose sodium, Dicalcium phosphate, Magnesium stearate, Microcrystalline cellulose, Phloxine B lake, Polyethylene glycol, Polyvinyl alcohol, Stearic acid, Talc, Titanium dioxide

  • Questions ?

    call toll-free 1-844-912-4012

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC55681-323-03

    Compare to active ingredients of Benadryl ®Allergy Tablets*

    ALLERGY RELIEF

    DIPHENHYDRAMINE HCl

    ANTIHISTAMINE

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

    ITEM#PCOTC124

    Distributed by:
    Twin Med LLC
    Santa Fe Springs, CA 90670
    www.procureproducts.com

    MADE IN THE U.S.A

    label

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55681-323
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULE (Caplet) Size11mm
    FlavorImprint Code D25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55681-323-03300 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/01/2024
    Labeler - TWIN MED LLC (009579330)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health Pharma USA LLC080804485manufacture(55681-323)
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