Label: FREE AND PURE ALLERGY RELIEF DYE FREE- diphenhydramine hcl capsule, liquid filled

  • NDC Code(s): 0363-1175-24, 0363-1175-48
  • Packager: WALGREEN COMPANY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 22, 2023

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  • Active ingredient (in each softgel)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing, runny nose, itchy, watery eyes, itching of the nose or throat
    • temporarily relieves these symptoms due to 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.

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

  • Directions

    • take every 4 to 6 hours
    • do not take more than 6 doses in 24 hours
    • adults and children 12 years of age and over - take 1 to 2 softgels
    • children 6 to under 12 years of age              - take 1 softgel
    • children under 6 years of age                      - do not use
  • Other information

    • store between 20-25ºC (68 to 77°F). Avoid high humidityandexcessive heat.
    • Protect from light, heat, humidity
  • Inactive ingredients

    gelatin, glycerin, polyethylene glycol-400, propylene glycol, povidone, purified water, sorbitol sorbitan solution

  • Questions or comments?

    1-800-373-6981

  • SPL UNCLASSIFIED SECTION

    Distributed By:
    Walgreen Co.
    200 Wilmot Rd., Deerfield, IL 60015

  • PRINCIPAL DISPLAY PANEL

    Free & Pure Dye-Free
    Allergy Relief


    Diphenhydramine HCl 25 mg/Antihistamine

    Relieves:
    Sneezing
    Itchy throat
    Runny nose
    Itchy, watery eyes

    Dye-Free Allergy Relief 24 ct

    Dye-Free Allergy Relief 48 ct

  • INGREDIENTS AND APPEARANCE
    FREE AND PURE ALLERGY RELIEF  DYE FREE
    diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1175
    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
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code SD12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1175-242 in 1 CARTON10/22/2023
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-1175-484 in 1 CARTON10/22/2023
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)10/22/2023
    Labeler - WALGREEN COMPANY (008965063)
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