Label: ALLERGY- diphenhydramine hcl tablet

  • NDC Code(s): 69168-048-01, 69168-048-20, 69168-048-93, 69168-048-98
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 7, 2018

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  • Active ingredient

    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:

    • sneezing
    • runny nose
  • Warnings

    Do not use

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

    Ask a doctor 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

    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 more than 6 times in 24 hours

       adults and children 12 years and over: 1 to 2 caplets

       children 6 to under 12 years: 1 caplet

       children under 6 years of age: do not use

  • Inactive Ingredients

    croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

  • Package/Label Principal Display Panel

    Diphenhydramine HCl 25mg

    Diphenhydramine HCl 25mg

  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-048
    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)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize12mm
    FlavorImprint Code AZ048
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-048-932 in 1 BOX12/15/2014
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:69168-048-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/15/2014
    3NDC:69168-048-20600 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2020
    4NDC:69168-048-98200 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/15/2014
    Labeler - Allegiant Health (079501930)
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