CHILDRENS EMETROL DYE FREE GRAPE- phosphorated carbohydrate solution 
WellSpring Pharmaceutical Corporation

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.

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Children's Emetrol Dye-Free Grape
WellSpring Pharmaceutical Corporation

DRUG FACTS

Active ingredients

Phosphorated carbohydrate solution*
    *Each 5 mL contains:
        • 3.74g Total sugar
        • 21.5mg 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 persons 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. (1-800-222-1222)

Directions

  • This product does not contain directions or complete warnings for adult use.
  • For maximum effectiveness never dilute or drink fluids of any kind immediately before or after taking this product
  • Children 2 to under 12: one or two teaspoons
  • Repeat dose every 15 minutes or until distress subsides
  • Do not take more than 5 doses in 1 hour without consulting a doctor
  • Measure only wih the dosing cup provided. Dosing cup to be used with Emetrol only. Do not use with other products.

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

Flavors, glycerin, methylparaben, and purified water.

Questions or comments?

call 1-866-337-4500

Distributed by:

WellSpring Pharmaceutical Corporation
Sarasota, FL 34243 USA
© WellSpring 2013
Made in Canada

PACKAGE LABEL

 Bottle Label

PACKAGE LABEL

Children's Emetrol Carton
CHILDRENS EMETROL DYE FREE GRAPE 
phosphorated carbohydrate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-212
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SUCROSE (UNII: C151H8M554) (SUCROSE - UNII:C151H8M554) SUCROSE3.74 g  in 5 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID21.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65197-212-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER04/21/201309/30/2016
Labeler - WellSpring Pharmaceutical Corporation (110999054)

Revised: 12/2014
Document Id: 1f81e745-3890-4144-84e7-84fb810f2dca
Set id: e8845159-361e-4a33-a1c3-d68864b31dbd
Version: 19
Effective Time: 20141202
 
WellSpring Pharmaceutical Corporation