leader 831.000/831aa

SPL v4

SPL

SPL Set ID 803f444f-d136-4f06-9842-24a71a3d7d6b

Route

oral

Published

Effective Date 2025-08-11

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

mineral oil (999 mg)

Inactive Ingredients

tocopherol

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2023-04-17

Purpose

Lubricant laxative

Description

Mineral oil 99.9%

Medication Information

Warnings

for this product

Purpose

Lubricant laxative

Directions

do not take with meals
take only at bedtime
may be taken as a single daily dose or in divided doses

adults and children 12 years of age and over - 1 to 3 Tablespoons (15 to 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours

children 6 to under 12 years of age - 1 to 3 teaspoons (5 to 15 mL) maximum 3 teaspoons (15 mL) in 24 hours

children under 6 years of age - do not use, consult a doctor

Other Information

keep tightly closed. Protect from sunlight.

Inactive Ingredients

mixed tocopherols (added as a stabilizer)

Description

Mineral oil 99.9%

Principal Display Panel

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

LEADER™

NDC 70000-0663-1

Mineral Oil

Lubricant Laxative

For relief of occasional constipation

100% Money back Guarantee

Odorless Tasteless, Colorless

16 FL OZ (1 PT) 473 mL

Questions?

1-888-593-0593

Use

for relief of occasional constipation (irregularity). Generally produces bowel movement in 6 to 8 hours.

Do Not Use

if you have difficulty swallowing
in children under 6 years of age
if you are pregnant
for a period longer than 1 week
if you are bedridden or aged

Adverse Reaction

DIST. BY CAH DUBLIN, OH 43017

www.myleader.com

1-800-200-6313

Active Ingredient

Mineral oil 99.9%

If Breast Feeding,

ask a health professional before use.

When Using This Product

do not take with meals. Take only at bedtime.

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.

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

abdominal pain, nausea, or vomiting
noticed a sudden change in bowel habits that persists over a period of 2 weeks

Ask A Doctor Or Pharmacist Before Use If You Are

presently taking a stool softener laxative
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

Warnings

for this product

Purpose

Lubricant laxative

Directions

do not take with meals
take only at bedtime
may be taken as a single daily dose or in divided doses

adults and children 12 years of age and over - 1 to 3 Tablespoons (15 to 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours

children 6 to under 12 years of age - 1 to 3 teaspoons (5 to 15 mL) maximum 3 teaspoons (15 mL) in 24 hours

children under 6 years of age - do not use, consult a doctor

Other Information

keep tightly closed. Protect from sunlight.

Inactive Ingredients (Inactive ingredients)

mixed tocopherols (added as a stabilizer)

Principal Display Panel

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

LEADER™

NDC 70000-0663-1

Mineral Oil

Lubricant Laxative

For relief of occasional constipation

100% Money back Guarantee

Odorless Tasteless, Colorless

16 FL OZ (1 PT) 473 mL

Questions?

1-888-593-0593

Use

for relief of occasional constipation (irregularity). Generally produces bowel movement in 6 to 8 hours.

Do Not Use (Do not use)

if you have difficulty swallowing
in children under 6 years of age
if you are pregnant
for a period longer than 1 week
if you are bedridden or aged

Adverse Reaction (Adverse reaction)

DIST. BY CAH DUBLIN, OH 43017

www.myleader.com

1-800-200-6313

Active Ingredient (Active ingredient)

Mineral oil 99.9%

If Breast Feeding, (If breast-feeding,)

ask a health professional before use.

When Using This Product (When using this product)

do not take with meals. Take only at bedtime.

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.

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)

abdominal pain, nausea, or vomiting
noticed a sudden change in bowel habits that persists over a period of 2 weeks

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

presently taking a stool softener laxative
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": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "ACTIB", "strengthNumerator": "999", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "for relief of occasional constipation (irregularity). Generally produces bowel movement in 6 to 8 hours.", "Purpose": "Lubricant laxative", "Warnings": "for this product", "Directions": "do not take with meals take only at bedtime may be taken as a single daily dose or in divided doses adults and children 12 years of age and over - 1 to 3 Tablespoons (15 to 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours children 6 to under 12 years of age - 1 to 3 teaspoons (5 to 15 mL) maximum 3 teaspoons (15 mL) in 24 hours children under 6 years of age - do not use, consult a doctor", "Do not use": "if you have difficulty swallowing in children under 6 years of age if you are pregnant for a period longer than 1 week if you are bedridden or aged", "Questions?": "1-888-593-0593", "Adverse reaction": "DIST. BY CAH DUBLIN, OH 43017 www.myleader.com 1-800-200-6313", "Active ingredient": "Mineral oil 99.9% ", "Other Information": "keep tightly closed. Protect from sunlight. ", "If breast-feeding,": "ask a health professional before use.", "Inactive ingredients": "mixed tocopherols (added as a stabilizer)", "Principal Display Panel": "SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION LEADER™ NDC 70000-0663-1 Mineral Oil Lubricant Laxative For relief of occasional constipation 100% Money back Guarantee Odorless Tasteless, Colorless 16 FL OZ (1 PT) 473 mL", "When using this product": "do not take with meals. Take only at bedtime.", "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.", "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": "abdominal pain, nausea, or vomiting noticed a sudden change in bowel habits that persists over a period of 2 weeks", "Ask a doctor or pharmacist before use if you are": "presently taking a stool softener laxative 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

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Source: dailymed · Ingested: 2026-02-15T12:08:28.943322 · Updated: 2026-03-14T23:12:42.073607