DYE FREE CHILDRENS DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [PRECISION DOSE, INC.]

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  • DYE FREE CHILDRENS DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [PRECISION DOSE, INC.]

DYE FREE CHILDRENS DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [PRECISION DOSE, INC.]
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NDC 68094-022-59, 68094-022-62, 68094-024-59, 68094-024-62
Set ID 139f7be5-c361-492c-ba3a-573ced661857
Category HUMAN OTC DRUG LABEL
Packager Precision Dose, Inc.
Generic Name
Product Class
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)

    Diphenhydramine HCl 12.5 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
  • Warnings

    Do not use

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

    Ask a doctor before use if the child has

    • a breathing problem such as chronic bronchitis
    • glaucoma
    • a sodium-restricted diet

    Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers.

    When using this product

    • marked drowsiness may occur
    • sedatives and tranquilizers may increase drowsiness
    • excitability may occur, especially in children

    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

    • Use as directed per healthcare professional.
    • do not take more than 6 doses in 24 hours
    • take every 4 to 6 hours, or as directed by a doctor
    • mL = milliliter
    • find the right dose on the chart below
    Age (yr)Dose (mL)
    children 6 to 11 years5 mL to 10 mL
    children 2 to 5 yearsdo not use unless directed by a doctor
    children under 2 yearsdo not use
  • Other information

    • each 5 mL contains: sodium 8 mg
    • store between 20-25°C (68-77°F). Do not refrigerate.
    • protect from light.
    • see individual label or shipper for lot number and expiration date.
  • Inactive ingredients

    carboxymethylcellulose sodium, citric acid, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol

  • SPL UNCLASSIFIED SECTION

    Alcohol Free, Dye Free

  • How Supplied

    NDC 68094-022-62
    5 mL per unit dose cup
    Thirty (30) cups per shipper

    NDC 68094-024-62
    10 mL per unit dose cup
    Thirty (30) cups per shipper

  • QUESTIONS

    For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    PL Developments
    Lynwood, CA 90262

    Packaged by:
    Precision Dose, Inc.
    South Beloit, IL 61080

    LI1156 Rev. 08/18

  • PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

    NDC 68094-022-59

    PrecisionDose™

    Children's DYE FREE
    diphenhydrAMINE HCl Liquid
    12.5 mg/5 mL

    Pkg: Precision Dose, Inc., S. Beloit, IL 61080

    PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
  • PRINCIPAL DISPLAY PANEL - 10 mL Cup Label

    NDC 68094-024-59

    PrecisionDose™

    Children's DYE FREE
    diphenhydrAMINE HCl Liquid
    25 mg/10 mL

    Delivers 10 mL, each 5 mL contains: sodium 8 mg
    Alcohol Free, Protect from light, Hospital Use Only

    Store between 20°-25°C (68°-77°F)
    Do not refrigerate
    Pkg. By: Precision Dose, Inc.
    South Beloit, IL 61080
    1158 R0

    PRINCIPAL DISPLAY PANEL - 10 mL Cup Label
  • INGREDIENTS AND APPEARANCE
    DYE FREE CHILDRENS DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-022(NDC:49580-0293)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68094-022-623 in 1 CASE12/27/2018
    110 in 1 TRAY
    1NDC:68094-022-595 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34112/27/2018
    DYE FREE CHILDRENS DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-024
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68094-024-623 in 1 CASE12/27/2018
    110 in 1 TRAY
    1NDC:68094-024-5910 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34112/27/2018
    Labeler - Precision Dose, Inc. (035886746)
    Establishment
    NameAddressID/FEIBusiness Operations
    P & L Development, LLC113044205MANUFACTURE(68094-022, 68094-024)
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