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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 13, 2024

If you are a consumer or patient please visit this version.

  • 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, UNSPECIFIED FORM (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE, UNSPECIFIED FORM1.87 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)