Label: ALLERGY RELIEF tablet

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

Drug Label Information

Updated January 26, 2024

If you are a consumer or patient please visit this version.

  • Active ingredient(s)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Use(s)

    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 before use if

    • 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

    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 breastfeeding,

    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 tablets

       children 6 to under 12 years: 1 tablet

       children under 6 years of age: do not use

  • Other information

    store at room temperature 20°– 25°C (68°– 77°F)

  • Inactive ingredients

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

  • Questions/Comments

    Call 1-888-952-0050 (Monday-Friday 9AM-5PM EST)

  • Principal Display Panel

    Allergy Relief

    Allergy Relief

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    allergy relief tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-048
    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 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize12mm
    FlavorImprint Code 048
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-048-9312 in 1 BLISTER PACK01/26/2024
    124 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/26/2024
    Labeler - Good Sense (076059836)