FDA.reportPublic FDA data

Emetrol Chewables Orange

Manufacturer
WellSpring Pharmaceutical Corporation
Effective date
2023-03-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:51:39

Label at a glance#

ProductEmetrol Chewables Orange
Active ingredientTRISODIUM CITRATE DIHYDRATE
Label structure10 sections

Indications and uses

For the relief of nausea associated with upset/sour stomach, including that due to overindulgence in food and drink.

Dosage and administration

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 u...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

  • Sodium citrate dihydrate USP 230 mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever

Uses

INDICATIONS & USAGE SECTION

For the relief of nausea associated with upset/sour stomach, including that due to overindulgence in food and drink.

Warnings

WARNINGS SECTION

Do not use if you have

OTC - DO NOT USE SECTION

  • Hereditary Fructose Intolerance (HFI). This product contains fructose.

Ask a doctor before use if you 

OTC - ASK DOCTOR SECTION

  • have diabetes because this product contains sugar
  • are on a sodium-restricted diet

Ask a doctor or pharmacist before use if

SPL UNCLASSIFIED SECTION

  • you are taking any other medications. This product may interact with certain prescription drugs.

When using this product,

SPL UNCLASSIFIED SECTION

  • do not take more than 24 tablets in a 24-hour period.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nausea lasts more than two weeks or recurs frequently.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • 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

INACTIVE INGREDIENT SECTION

dextrose, flavor, fructose, hydroxypropyl cellulose, magnesium stearate, maltodextrin, silica, sodium carboxymethylcellulose, sucralose.

Questions or Comments?

SPL UNCLASSIFIED SECTION

1-844-241-5454 or Emetrol.com 

Distributed By

SPL UNCLASSIFIED SECTION

WellSpring Pharmaceutical Corporation
Sarasota, FL 34243
(c) 2023 WellSpring Pharmaceutical Corporation

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

# 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

Emetrol Chewables Orange
Emetrol Chewables Orange

Side Panels

SPL UNCLASSIFIED SECTION

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2596185Emetrol Chewables 230 MG Chewable TabletPSN4
2002800sodium citrate 230 MG Chewable TabletPSN4
2596185sodium citrate 230 MG Chewable Tablet [Emetrol Chewables]SBD4
2002800sodium citrate 230 MG Chewable TabletSCD4
2596185Emetrol Chewables 230 MG Chewable TabletSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-410-60Emetrol Chewables Orange60 in 1 BOTTLETABLET, CHEWABLE604
65197-410-60Emetrol Chewables Orange1 in 1 BOXTABLET, CHEWABLE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-410EMETROL CHEWABLES ORANGE (SODIUM CITRATE DIHYDRATE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]4Current NDC, 2 package rows20250110_e9072f9d-d74c-4e43-bcfe-ee005577df35.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65197-41065197-410-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRISODIUM CITRATE DIHYDRATEB22547B95KACTIM
DEXTROSEIY9XDZ35W2IACT
FRUCTOSE6YSS42VSEVIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Emetrol Chewables OrangeSODIUM CITRATE DIHYDRATEWellSpring Pharmaceutical Corporatione9072f9d-d74c-4e43-bcfe-ee005577df352023-03-23WarningsExact identifier
ndc (package): 65197-410-60
ndc (product): 65197-410
ndc11 (package): 65197041060
spl id: f2a2843d-3b10-4160-9334-8e4637e5176e
spl set id: e9072f9d-d74c-4e43-bcfe-ee005577df35

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.