FDA.reportPublic FDA data

Leader 602.002/602AA

Manufacturer
Cardinal Health, 110 dba Leader | Nice-Pak Products, LLC
Effective date
2026-08-25
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
daily-update
Hydrated at
2026-08-27 00:02:01

Label at a glance#

ProductEpsom Salt
Active ingredientMAGNESIUM SULFATE HEPTAHYDRATE
Label structure17 sections

Indications and uses

for relief of occasional constipation (irregularity) this product generally produces bowel movement in 1/2 to 6 hours

Dosage and administration

do not exceed recommended daily dosage drink a full glass (8 ounces) of liquid with each dose may be taken as a single daily dose or in divided doses dissolve the dose in 8 ounces of water. Lemon juice may be added to improve the taste. adults and children 12 years and over - 2 to 6 level teaspoons (10 to 30 grams) daily children 6 to under 12 years - 1 to 2 level teaspoons (5 to 10 grams) daily children under 6 y...

Label contents#

Full prescribing information#

Tamper Evident Statement

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT PACKAGING:

CAUTION: THIS PACKAGE HAS BEEN SEALED FOR YOUR PROTECTION.

DO NOT USE IF PACKAGE IS OPEN, TORN OR MUTILATED

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Magnesium sulfate USP (heptahydrate)100%

Purpose

OTC - PURPOSE SECTION

Saline Laxative

Uses

INDICATIONS & USAGE SECTION

  • for relief of occasional constipation (irregularity)
  • this product generally produces bowel movement in 1/2 to 6 hours

Warnings

WARNINGS SECTION

for this product

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • kidney disease
  • a magnesium-restricted diet
  • abdominal pain, nausea, or vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks
  • already used a laxative for a period longer than 1 week

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

OTC - STOP USE SECTION

you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

If pregnant 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not exceed recommended daily dosage
  • drink a full glass (8 ounces) of liquid with each dose
  • may be taken as a single daily dose or in divided doses
  • dissolve the dose in 8 ounces of water. Lemon juice may be added to improve the taste.

adults and children 12 years and over - 2 to 6 level teaspoons (10 to 30 grams) daily

children 6 to under 12 years - 1 to 2 level teaspoons (5 to 10 grams) daily

children under 6 years - consult a doctor

Other information

OTHER SAFETY INFORMATION

  • each teaspoon (5 grams) contains: magnesium 495 mg

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

Questions?

OTC - QUESTIONS SECTION

1-888-593-0593

claims

SPL UNCLASSIFIED SECTION

For external use as a soaking aid for minor sprains and bruises.

Directions: For a relaxing bath/soak, liberally sprinkle LEADER™ Epsom Salt into warm, running bath water

Caution: IF PROMPT RELIEF IS NOT OBTAINED OR THERE IS EVIDENCE OF INFECTION, DISCONTINUE USE AND CONSULT YOUR PHYSICIAN. HOT OR WARM SOAKS SHOULD NOT BE USED BY INDIVIDUALS WITH DIABETES EXCEPT ON THE ADVICE OF A PHYSICIAN. KEEP OUT OF REACH OF CHILDREN.

Adverse reactions section

©2026 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER and the Leader LOGO are trademarks or registered trademarks of Cardinal Health.

Cardinal Health™

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Essential to Care™ since 1979

ALL LEADER™ Brand Products Have A 100% Money Back Guarantee

Return to place of purchase if not satisfied.

CIN 5516083  REV 7/26

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CUT ALONG DOTTED LINE AND PRESS ZIPPER TO RESEAL.

LEADER™

NDC 70000-0021-1

Epsom Salt

Magnesium Sulfate USP, 100%

Saline Laxative

Saline Laxative

For Relief of Occasional Constipation

Soaking Aid

For Minor Sprains and Bruises

100% Money Back Guarantee

NET WT 1 LB (454 g)

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
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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
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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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0021-1GM - Gram70000-002188970ac1-d53e-4fa0-81ee-2e83fe635f6112020-01-03
70000-0021-2GM - Gram70000-0021100f5230-e126-415c-9d76-898328c984b212020-01-03

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
70000-002170000-0021-2, 70000-0021-1

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 HEPTAHYDRATESK47B8698TACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
162026-01-29full-release2026-06-01 01:36:02

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, 110 dba Leaderd27dc1cc-5e17-40d3-84fe-c1792552cfd52026-08-25Warnings, Adverse reactionsExact identifier
ndc (package): 70000-0021-2
ndc (package): 70000-0021-1
ndc (product): 70000-0021
ndc11 (package): 70000002101
ndc11 (package): 70000002102
spl id: 59e271e7-8104-0de2-e063-6394a90abebb
spl set id: d27dc1cc-5e17-40d3-84fe-c1792552cfd5

Reported adverse events (FAERS/openFDA)#

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