Active Ingredients
- Sodium citrate dihydrate USP 230 mg
Emetrol Chewables Orange Tablet, Chewable
FDA Label NDC 65197-410
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 Chewables Orange (NDC 65197-410). 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, do not use if you have, ask a doctor before use if you, ask a doctor or pharmacist before use if, when using this product,, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Upset stomach reliever/antacid
Uses
For the relief of nausea associated with upset/sour stomach, including that due to overindulgence in food and drink.
Do Not Use If You Have
- Hereditary Fructose Intolerance (HFI). This product contains fructose.
Ask A Doctor Before Use If You
- have diabetes because this product contains sugar
- are on a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If
- you are taking any other medications. This product may interact with certain prescription drugs.
When Using This Product,
- do not take more than 24 tablets in a 24-hour period.
Stop Use And Ask A Doctor If
- nausea lasts more than two weeks or recurs frequently.
If Pregnant Or Breast-Feeding,
- ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- Adults: 2-4 tablets.
- Children: Consult a doctor for appropriate dosage.
- Chew tablets completely. Do not swallow whole
- Dosage may be repeated after 15 minutes, not to exceed 24 tablets in a 24-hour period unless advised by a doctor.
- Read all package directions and warnings before use and use only as directed.
- These tablets are intended for use by normally healthy persons only.
- Persons under 18 years of age should use only as directed by a doctor.
Other Information
- Each table contains: Sodium 60mg
- Store at room temperature
- Protect product from excessive heat, cold and moisture
- Note: This product is not intended as a substitute for a balanced nutritional diet or as an electrolyte replenishment.
- Do not use if printed seal under cap is broken or missing.
Inactive Ingredients
dextrose, flavor, fructose, hydroxypropyl cellulose, magnesium stearate, maltodextrin, silica, sodium carboxymethylcellulose, sucralose.
Questions Or Comments?
1-844-241-5454 or Emetrol.com
Distributed By
WellSpring Pharmaceutical Corporation
Sarasota, FL 34243
(c) 2023 WellSpring Pharmaceutical Corporation
Package Label
# 1 Pharmacist Recommended
New
Non-Drowsy
Emetrol Chewable Rapid Nausea Relief
Treats the source of Nausea*
*Due to overindulgence in food and drink
Powerful, Soothing Relief
Orange Flavor
60 Chewable Tablets
Ifc Emetrol Chewable Tablet Orange (Emetrol Chewables Orange 1)
Side Panels
Emetrol Chewables Rapid Nausea Relief
Non-Drowsy
Treats the source of Nausea*
Specially Formulated for Adults
Great-tasting Lemon Chewables
*Due to overindulgence in food and drink
Emetrol Chewables relieves stomach discomfort with:
No Acetaminophen
No Aspirin
No Caffeine
* Please review the disclaimer below.
