Emetrol Children Mixed Berry Solution
FDA Label NDC 65197-202

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wellspring Pharmaceutical Corporation for the product Emetrol Children Mixed Berry (NDC 65197-202). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use if the child has, ask a doctor before use if the child has, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Do Not Use If The Child Has

→ Ask A Doctor Before Use If The Child Has

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Distributed By

→ Package Label

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 20-25°C (68-77°F) away from heat and direct light; keep from freezing
Do not use if printed foil seal under bottle cap is broken or missing