DYE FREE ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]

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DYE FREE ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]
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NDC 63868-128-04
Set ID f1a33c2f-2330-43f3-8026-de21808aec66
Category HUMAN OTC DRUG LABEL
Packager QUALITY CHOICE (Chain Drug Marketing Association)
Generic Name
Product Class
Product Number
Application Number PART341
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  • 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 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

    • do not take more than 6 doses in 24 hours
    • take every 4 to 6 hours, or as directed by a doctor
    • measure only with dosing cup provided. Do not use any other dosing device. 
    • mL = milliliter
    • keep dosing cup with product 
    • 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 years do 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. Store in outer carton until contents are used.
  • Inactive ingredients

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

  • Questions or comments?

     Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    *Compare to the active ingredient in Children's Benadryl® Allergy

    Dye-Free

    Children's

    Allergy

    Antihistamine

    Diphenhydramine Hydrochloride 12.5mg / 5 mL Oral Solution

    Liquid Medication

    Relieves

    Runny Nose | Sneezing |

    Itchy, Watery Eyes | Itchy Throat

    For Ages 6 to 11 Years

    Alcohol-Free

    Dye-Free

    Bubble Gum Flavored

    FL OZ (mL)

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Benadryl® Allergy.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

    Distributed by C.D.M.A., Inc,©

    43157 W.Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

  • Package Label

    Diphenhydramine HCI 12.5 mg

    QUALITY CHOICE Dye-Free Children's Allergy

  • INGREDIENTS AND APPEARANCE
    DYE FREE ALLERGY  CHILDRENS
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-128
    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 (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:63868-128-041 in 1 BOX02/29/2016
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/29/2016
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
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