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Emetrol Cherry

Emetrol

Approved
Approval ID

a8469128-592a-4682-82c7-4d2a6f97a998

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 10, 2025

Manufacturers
FDA

WellSpring Pharmaceutical Corporation

DUNS: 110999054

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

phosphorated carbohydrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code65197-201
Product Classification
G
Generic Name
phosphorated carbohydrate
Product Specifications
Route of AdministrationORAL
Effective DateJune 10, 2025
FDA Product Classification

INGREDIENTS (7)

DEXTROSEActive
Quantity: 1.87 g in 5 mL
Code: IY9XDZ35W2
Classification: ACTIB
PHOSPHORIC ACIDActive
Quantity: 21.5 mg in 5 mL
Code: E4GA8884NN
Classification: ACTIB
FRUCTOSEActive
Quantity: 1.87 g in 5 mL
Code: 6YSS42VSEV
Classification: ACTIB
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/10/2025

PACKAGE LABEL

Emetrol Loquid Rapid Nausea Relief

Treats the source of Nausea & upset stomach

Emetrol 4 fl oz

CT201048H

Emetrol 12 fl oz

Emetrol 12 oz

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/8/2025

Uses

For relief of upset stomach associated with nausea due to overindulgence in food and drink.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/8/2025

Active ingredients

Phosphorated carbohydrate solution*
*each 5 mL contains:

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/8/2025

Purpose

Upset Stomach Reliever

WARNINGS SECTION

LOINC: 34071-1Updated: 1/8/2025

Warnings

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

Do not use if you have

  • allergic reactions to any of the ingredients in this product

Ask a doctor before use if you have

  • diabetes

Stop use and ask a doctor if

  • symptoms persist, return or get worse

If pregnant or breast-feeding,

ask a health professional before use.

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)

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/8/2025

Directions

  • for maximum effectiveness never dilute or drink fluids of any kind immediately before or after taking this product
  • adults and children 12 years of age and over: one to two tablespoons
  • 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 with dosing cup provided. Dosing cup to be used with Emetrol only. Do not use with other products.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 1/8/2025

Distributed By

WellSpring Pharmaceutical Corporation
Sarasota, FL 34243 USA
(c) WellSpring 2019

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/8/2025

Inactive ingredients

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

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Emetrol Cherry - FDA Drug Approval Details