DYE-FREE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]

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DYE-FREE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]
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NDC 51013-144-04
Set ID ed3be505-045d-4ebd-b4ea-7f04ceadfe6a
Category HUMAN OTC DRUG LABEL
Packager PuraCap Pharmaceutical LLC
Generic Name
Product Class
Product Number
Application Number PART341
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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 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 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 toll free: 1-800-833-6278

  • PRINCIPAL DISPLAY PANEL

    DYE-FREE ALLERGY 24 SOFTGELS

    Diphenhydramine HCl 25mg

    NDC 51013-144-04

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

    Carton Label

  • INGREDIENTS AND APPEARANCE
    DYE-FREE ALLERGY 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-144
    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:51013-144-042 in 1 CARTON06/27/2016
    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 finalpart34106/27/2016
    Labeler - PuraCap Pharmaceutical LLC (962106329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(51013-144) , analysis(51013-144)
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