FDA.reportPublic FDA data

Epsom Salt

Manufacturer
SMART SENSE (Kmart)
Effective date
2020-11-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:07:27

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 Ingredients

INACTIVE INGREDIENT SECTION

None

Questions or comments?

OTC - QUESTIONS SECTION

 For laxative or soak Call toll free 1-800-842-7886

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

EPSOM SALTS

MAGNESIUM SULFATE USP 

SALINE LAXATIVE

SOAKING AID FOR

minor sprains • bruises

NET WT  OZ  ( LB) KG

Distributed by: Kmart Corporation

Hoffman Estates, IL 60179

shop kmart.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SMART SENSE Epsom Salt
SMART SENSE Epsom Salt

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49738-395-012024-05-24C16284748780-1d6a99b39-cd1d-a426-e053-dadaa90af4c2Drug Facts
49738-395-042024-05-24C16284748780-1d6a99b39-cd1d-a426-e053-dadaa90af4c2Drug Facts
49738-395-062024-05-24C16284748780-1d6a99b39-cd1d-a426-e053-dadaa90af4c2Drug Facts
49738-395-012022-01-28C16284748780-1d6a99b39-cd1d-a426-e053-dadaa90af4c2Drug Facts
49738-395-042022-01-28C16284748780-1d6a99b39-cd1d-a426-e053-dadaa90af4c2Drug Facts
49738-395-062022-01-28C16284748780-1d6a99b39-cd1d-a426-e053-dadaa90af4c2Drug Facts

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49738-39549738-395-01, 49738-395-04, 49738-395-06

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
b5e1c773-1d3d-4f9c-85b6-f3ffe03a4d3c708ed5a1-7808-490d-9b1f-fa36aa709a572024-05-24WarningsExact identifier
spl set id: 708ed5a1-7808-490d-9b1f-fa36aa709a57

Reported adverse events (FAERS/openFDA)#

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