Label: ALLERGY RELIEF- diphenhydramine hydrochloride tablet

  • NDC Code(s): 71679-106-01, 71679-106-06, 71679-106-10
  • Packager: Health Pharma USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 20, 2023

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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

    • With any other product containing diphenhydramine, even one used on skin
    • To make a child sleepy

    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 a doctor or pharmacist before use if youaretaking sedatives or tranquilizers

    When using this product

    • Marked drowsiness may occur
    • Avoid alcoholic drinks
    • Excitability may occur, especially in children 
    • Alcohol, sedatives and tranquilizers may increase drowsiness
    • Be careful when driving a motor vehicle or operating machinery
  • If pregnant or breast-feeding,

    ask a health professional before use

  • Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Prompt medical attention is critical for adults as well as for 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 not more than 6 doses in 24 hours

    • Adults and children 12 years  and over:1 or 2 caplets
    • Children 6 to under 12 years :1 caplet
    • Children under 6 years: do not use
  • Other Information

    • Each caplet contains: Calcium 23.52 mg
    • Store between 20-25°C (68-77°F)
    • Protct from light

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

  • Inactive Ingredients

    May Contains:

    Dicalcium Phosphate, Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid, Colloidal Silicon Dioxide, Magnesium Stearate, film coaat AMB pink, Polyethylene Glycol, Polyvinyl Alcohol, Phloxine B lake, Titanium dioxide, Talc

  • Questions or comments?

    Call 1-844-832-1138

    9 AM- 4 PM Monday - Friday

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Diphenhydramine Hydrochloride 25 mg/Antihistamine

    Compare to Benadryl ®  Allergy active ingredients*

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

    label

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71679-106
    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
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code D25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71679-106-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/12/2012
    2NDC:71679-106-06600 in 1 BOTTLE; Type 0: Not a Combination Product05/12/2012
    3NDC:71679-106-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/12/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/12/2012
    Labeler - Health Pharma USA LLC (080804485)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health Pharma USA LLC080804485manufacture(71679-106)
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