Label: ALLERGY RELIEF- diphenhydramine hydrochloride capsule, liquid filled

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

Drug Label Information

Updated November 24, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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:
      • runny nose
      • sneezing
      • itchy, watery eyes
      • itching of the nose or throat
    • temporarily relieves these symptoms due to the 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 aretaking 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 and over

         1 to 2 softgels

    children 6 to under 12 years

         1 softgel

    children under 6 years

         do not use this product in children under 6 years of age

  • Other information

    • store at room temperature 15°-30°C (59°-86°F) in a dry place
    • protect from heat, humidity, and light
  • Inactive ingredients

    gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

  • Questions or comments?

    Call:1-855-215-8180

  • PRINCIPAL DISPLAY PANEL - Carton Label

    CAREONE Allergy Relief

    Diphenhydramine HCl 25 mg 24 softgels

    NDC 41520-996-04

    *Compare to the active ingredient in Benadryl ®Dye-Free Allergy Liqui-Gels ®

    Carton Label

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-996
    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, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Coloryellow (clear) Scoreno score
    ShapeCAPSULE (oblong) Size15mm
    FlavorImprint Code PC4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-996-042 in 1 CARTON10/03/2016
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/03/2016
    Labeler - FOODHOLD U.S.A., LLC (809183973)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(41520-996)
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