FDA.reportPublic FDA data

Epsom Salt

Manufacturer
QUALITY CHOICE (Chain Drug Marketing Association)
Effective date
2023-05-02
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:31:53

Label at a glance#

ProductEpsom Salt
Active ingredientMAGNESIUM SULFATE, UNSPECIFIED
Label structure10 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces bowel movement in 1/2 to 6 hours

Dosage and administration

do not exceed more than 2 doses per day; if necessary repeat dosage in 4 hours age dose  adults and children 12  years and older 2-4 level teaspoons dissolved in a full glass (8oz) of water   children 6 to 11 years 1-2 level teaspoons dissolved in a full glass (8oz) of water Not recommended for children under 6 years of age.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Magnesium sulfate USP 100%

Purpose

OTC - PURPOSE SECTION

 Saline laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 1/2 to 6 hours

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • kidney disease
  • a magnesium restricted diet
  • stomach pain, nausea or vomiting
  • noticed a sudden change in bowel habits that lasts more than 2 weeks

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

 presently taking a prescription drug.

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding or failure to have a bowel movement after use. This may indicate a serious condition.
  • you need to use a laxative for more than 1 week

If pregnancy or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

 ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

 In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not exceed more than 2 doses per day; if necessary repeat dosage in 4 hours
agedose
 adults and children 12  years and older2-4 level teaspoons dissolved in a full glass (8oz) of water 
 children 6 to 11 years

1-2 level teaspoons dissolved in a full glass (8oz) of water


Not recommended for children under 6 years of age.

Other information

SPL UNCLASSIFIED SECTION

  • each teaspoon contains: magnesium 495 mg

Inactive ingredient

INACTIVE INGREDIENT SECTION

none 

Questions or comments?

OTC - QUESTIONS SECTION

For laxative or soak, call 1-248-449-9300 Monday- Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Epsom Salt

Saline Laxative

Magnesium Sulfate U.S.P.

Relieves Occasional Constipation

Soaking Aid For Minor Sprains and Bruises

Relief Throughout the Year

*Safety Sealed

Net WT LB (kg)

*TAMPER EVIDENT: DO NOT USE IF HEAT SEALED POUCH IS IMPROPERLY SEALED.

Distributed by: C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI 48375

www.qualitychoice.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY CHOICE Epsom Salt
QUALITY CHOICE Epsom Salt

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-937-042023-05-02C16284748780-1f386c64a-10fa-0266-e053-dadaa90a7c1aDrug Facts
63868-937-162023-05-02C16284748780-1f386c64a-10fa-0266-e053-dadaa90a7c1aDrug Facts
63868-937-042023-01-30C16284748780-1f386c64a-10fa-0266-e053-dadaa90a7c1aDrug Facts
63868-937-162023-01-30C16284748780-1f386c64a-10fa-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-937EPSOM SALT GRANULE [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]6Legacy NDC20230504_3b3ab0b0-af82-4e89-95bc-0766a952e4c1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-937-04GM - Gram63868-937659c38f6-83e0-4507-a15e-4a2e01a6282812019-11-12
63868-937-16GM - Gram63868-9371eb59b2c-a249-4e31-b9fa-579608dbd9d812018-02-20

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-93763868-937-16, 63868-937-04

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABACTIB

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
6b46f08f-1856-4354-976f-bd9362279a873b3ab0b0-af82-4e89-95bc-0766a952e4c12023-05-02WarningsExact identifier
spl id: 6b46f08f-1856-4354-976f-bd9362279a87
spl set id: 3b3ab0b0-af82-4e89-95bc-0766a952e4c1

Reported adverse events (FAERS/openFDA)#

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