FDA.reportPublic FDA data

Epsom Salt

Manufacturer
Cardinal Health (Leader) 70000
Effective date
2025-01-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:53:25

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 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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

None

Other information

SPL UNCLASSIFIED SECTION

  • each teaspoon contains: magnesium 495 mg

Questions or comments?

OTC - QUESTIONS SECTION

For laxative or soak, call 1-877-753-3935 Monday- Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Multi-purpose

Epsom Salt

Magnesium Sulfate USP, 100%

Saline Laxative

Relieves

Occasional Constipation

Soaking Aid for

Minor Sprains and Bruises

NET WT OZ  (LBS) kg

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

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER Multi-Purpose Epsom Salt
LEADER Multi-Purpose Epsom Salt

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053346Epsom salt 100 % Granules for Oral SolutionPSN3
1053346magnesium sulfate 1000 MG Granules for Oral SolutionSCD3
1053346Epsom salt 100 % Granules for Oral SolutionSY3
1053346magnesium sulfate 100 % Granules for Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0614-1Epsom Salt1814 g in 1 POUCHGRANULE18143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0614EPSOM SALT (MAGNESIUM SULFATE) GRANULE [CARDINAL HEALTH (LEADER) 70000]3Current NDC, 1 package rows20250123_cde87f95-73c0-46f5-9349-37e04096048c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0614-1GM - Gram70000-06146eaf577c-b9a9-4f30-b53b-dda9e15e6a2d12024-02-14

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
70000-061470000-0614-1

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
Epsom SaltMAGNESIUM SULFATECardinal Health (Leader) 70000cde87f95-73c0-46f5-9349-37e04096048c2025-01-22WarningsExact identifier
ndc (package): 70000-0614-1
ndc (product): 70000-0614
ndc11 (package): 70000061401
spl id: ecd3b0f8-5134-436a-a4e1-fdff06a335bf
spl set id: cde87f95-73c0-46f5-9349-37e04096048c

Reported adverse events (FAERS/openFDA)#

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