Label: EMETROL CHILDREN MIXED BERRY- phosphorated carbohydrate solution

  • NDC Code(s): 65197-202-14
  • Packager: WellSpring Pharmaceutical Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated May 22, 2023

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  • Active ingredients

    Phosphorated carbohydrate solution*
        *each 5 mL contains:

    • 1.87 g Dextrose (glucose)
    • 1.87 g Levulose (fructose)
    • 21.5 mg Phosphoric acid
  • Purpose

    Upset Stomach Reliever       

  • Uses

    For relief of upset stomach associated with nausea

  • Warnings

    • This product contains fructose and should not be taken by children with hereditary fructose intolerance (HFI).

    Do not use if the child has

    • allergic reactions to any of the ingredients in this product

    Ask a doctor before use if the child has

    • diabetes

    Stop use and ask a doctor if

    • symptoms persist, return or get worse

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away

  • Directions

    • for maximum effectiveness never dilute or drink fluids of any kind immediately before or after taking this product
    • repeat dose every 15 minutes or until distress subsides
    • Child should not take more than 5 doses in 1 hour without consulting a doctor
    • measure only with dosing cup provided. Dosing cup to be used with Emetrol only. Do not use with other products. mL= milliliter
    • children under 2 years - Do not use 
    • children 2 to under 12 years of age - 5 mL or 10mL
    • children 12 years of age and over - 15 mL or 30 mL
  • Other information

    • Store between 20-25ºC (68-77ºF) away from heat and direct light; keep from freezing
    • Do not use if printed foil seal under bottle cap is broken or missing
  • Inactive ingredients

    FD&C red no. 40, flavors, glycerin, methylparaben, and purified water.

  • Questions or Comments?

    call 1-844-241-5454 or www.emetrol.com

  • Distributed By

    WellSpring Pharmaceutical Corporation
    Sarasota, FL 34243 USA
    (c) WellSpring 2023

    Money  Back Guarantee

  • PACKAGE LABEL

    Treats the source by Calming Stomach Muscles

    Safe for children Ages 2 & Up

    Great-tasting Mixed Berry Liquid

    Free of:  Aspirin | Acetaminophen | Alcohol | Caffeine 

    Carton Emetrol Children's Liquid Mixed Berry

    Emetrol Children's Liquid Mixed Berry

  • INGREDIENTS AND APPEARANCE
    EMETROL CHILDREN MIXED BERRY 
    phosphorated carbohydrate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-202
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE (UNII: IY9XDZ35W2) (DEXTROSE - UNII:IY9XDZ35W2) DEXTROSE1.87 g  in 5 mL
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID21.5 mg  in 5 mL
    FRUCTOSE (UNII: 6YSS42VSEV) (FRUCTOSE - UNII:6YSS42VSEV) FRUCTOSE1.87 g  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorBERRY (Mixed Berry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65197-202-141 in 1 CARTON06/01/2023
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2023
    Labeler - WellSpring Pharmaceutical Corporation (110999054)
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