Leader 602.002/602aa

SPL v16

SPL

SPL Set ID d27dc1cc-5e17-40d3-84fe-c1792552cfd5

Routes

ORAL TOPICAL

Published

Effective Date 2025-07-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Magnesium Cation (1 g)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2012-03-26 Until 2026-05-23

Description

TAMPER EVIDENT PACKAGING: CAUTION: THIS PACKAGE HAS BEEN SEALED FOR YOUR PROTECTION. DO NOT USE IF PACKAGE IS OPEN, TORN OR MUTILATED

Purpose

Saline Laxative

Adverse Reactions

Cardinal Health™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care since 1979 ©2019 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. ALL LEADER™ Brand Product Have A 100% Money Back Guarantee Return to place of purchase if not satisfied. CIN 5516083 REV 4/19

Medication Information

Purpose

Saline Laxative

Adverse Reactions

Description

TAMPER EVIDENT PACKAGING: CAUTION: THIS PACKAGE HAS BEEN SEALED FOR YOUR PROTECTION. DO NOT USE IF PACKAGE IS OPEN, TORN OR MUTILATED

Uses

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

Claims

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.

Warning

for this product

Directions

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

Active Ingredient

Magnesium sulfate USP (heptahydrate)100%

Other Information

each teaspoon (5 grams) contains: magnesium 495 mg

Inactive Ingredient

None

Questions and Comments?

1-888-593-0593

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

Saine Laxative

For Relief of Occasional Constipation

Soaking Aid

For Minor Sprains and Bruises

100% Money Back Guarantee

Net WT 1 LB (454 g)

Tamper Evident Statement

TAMPER EVIDENT PACKAGING:

CAUTION: THIS PACKAGE HAS BEEN SEALED FOR YOUR PROTECTION.

DO NOT USE IF PACKAGE IS OPEN, TORN OR MUTILATED

Adverse Reactions Section

Cardinal Health™

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Essential to Care since 1979

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

Return to place of purchase if not satisfied.

CIN 5516083 REV 4/19

Stop Use and Ask A Doctor If

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,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have

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

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

Structured Label Content

Uses

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

Claims (claims)

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

Purpose

Saline Laxative

Warning

for this product

Directions

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

Active Ingredient (Active ingredient)

Magnesium sulfate USP (heptahydrate)100%

Other Information (Other information)

each teaspoon (5 grams) contains: magnesium 495 mg

Inactive Ingredient

None

Questions and Comments? (Questions and comments?)

1-888-593-0593

Principal Display Panel (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

Saine Laxative

For Relief of Occasional Constipation

Soaking Aid

For Minor Sprains and Bruises

100% Money Back Guarantee

Net WT 1 LB (454 g)

Tamper Evident Statement

TAMPER EVIDENT PACKAGING:

CAUTION: THIS PACKAGE HAS BEEN SEALED FOR YOUR PROTECTION.

DO NOT USE IF PACKAGE IS OPEN, TORN OR MUTILATED

Adverse Reactions Section (Adverse reactions section)

Cardinal Health™

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Essential to Care since 1979

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

Return to place of purchase if not satisfied.

CIN 5516083 REV 4/19

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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 (Ask a doctor or pharmacist before use if you are)

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

Advanced Ingredient Data

[{"name": "MAGNESIUM CATION", "unii": "T6V3LHY838", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "for relief of occasional constipation (irregularity) this product generally produces bowel movement in 1/2 to 6 hours", "claims": "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.", "Purpose": "Saline Laxative", "Warning": "for this product", "Directions": "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", "Active ingredient": "Magnesium sulfate USP (heptahydrate)100%", "Other information": "each teaspoon (5 grams) contains: magnesium 495 mg", "Inactive Ingredient": "None", "Questions and comments?": "1-888-593-0593", "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 Saine Laxative For Relief of Occasional Constipation Soaking Aid For Minor Sprains and Bruises 100% Money Back Guarantee Net WT 1 LB (454 g)", "Tamper Evident Statement": "TAMPER EVIDENT PACKAGING: CAUTION: THIS PACKAGE HAS BEEN SEALED FOR YOUR PROTECTION. DO NOT USE IF PACKAGE IS OPEN, TORN OR MUTILATED", "Adverse reactions section": "Cardinal Health™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care since 1979 ©2019 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. ALL LEADER™ Brand Product Have A 100% Money Back Guarantee Return to place of purchase if not satisfied. CIN 5516083 REV 4/19", "Stop use and ask a doctor if": "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,": "ask a health professional before use.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away.", "Ask a doctor before use if you have": "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": "taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:29.013381 · Updated: 2026-03-14T23:12:44.067976