leader 078.000/078aa

SPL v17

SPL

SPL Set ID 49e3a40a-b717-43f6-abed-473d7ed03c2e

Route

oral

Published

Effective Date 2026-01-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

castor oil (1 g)

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2019-03-12

Adverse Reactions

Purpose

Stimulant Laxative

Description

Castor oil USP 100%

Medication Information

Warnings

for this product

Purpose

Stimulant Laxative

Directions

Adults and children over 12 years of age: 1 to a maximum of 4 tablespoons (15 to 60 mL) in a single daily dose
Children 2 to under 12 years of age: 1 to a maximum of 3 teaspoons (5 to 15 mL) in a single daily dose
Children under 2 years of age: do not use, consult a doctor

Adverse Reactions

Dist. by CAH, Dublin, OH 43017

CIN 5516034 REV. 09/25

Other Information

Keep tightly closed, away from excessive heat.

Description

Castor oil USP 100%

Principal Display Panel

LEADER ™

NDC 70000-0024-1

Castor Oil USP

Stimulant Laxative

100% Money Back Guarantee

For the Relief of Occasional Constipation

4 FL OZ (118 mL)

DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING.

Questions?

1-888-593-0593

Use

For relief of occasional constipation (irregularity). Generally produces bowel movement in 6 to 12 hours.

Do Not Use

for a period longer than 1 week

Active Ingredient

Castor oil USP 100%

Inactive Ingredient

none

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

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

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

Stimulant Laxative

Directions

Adults and children over 12 years of age: 1 to a maximum of 4 tablespoons (15 to 60 mL) in a single daily dose
Children 2 to under 12 years of age: 1 to a maximum of 3 teaspoons (5 to 15 mL) in a single daily dose
Children under 2 years of age: do not use, consult a doctor

Adverse Reactions (Adverse reactions)

Dist. by CAH, Dublin, OH 43017

CIN 5516034 REV. 09/25

Other Information (Other information)

Keep tightly closed, away from excessive heat.

Principal Display Panel (principal display panel)

LEADER ™

NDC 70000-0024-1

Castor Oil USP

Stimulant Laxative

100% Money Back Guarantee

For the Relief of Occasional Constipation

4 FL OZ (118 mL)

DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING.

Questions?

1-888-593-0593

Use

For relief of occasional constipation (irregularity). Generally produces bowel movement in 6 to 12 hours.

Do Not Use (Do not use)

for a period longer than 1 week

Active Ingredient (Active ingredient)

Castor oil USP 100%

Inactive Ingredient (INACTIVE INGREDIENT)

none

Stop Use and Ask A Doctor (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)

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)

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": "CASTOR OIL", "unii": "D5340Y2I9G", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "For relief of occasional constipation (irregularity). Generally produces bowel movement in 6 to 12 hours.", "Purpose": "Stimulant Laxative", "Warnings": "for this product", "Directions": "Adults and children over 12 years of age: 1 to a maximum of 4 tablespoons (15 to 60 mL) in a single daily dose Children 2 to under 12 years of age: 1 to a maximum of 3 teaspoons (5 to 15 mL) in a single daily dose Children under 2 years of age: do not use, consult a doctor", "Do not use": "for a period longer than 1 week", "Questions?": "1-888-593-0593", "Active ingredient": "Castor oil USP 100%", "Adverse reactions": "Dist. by CAH, Dublin, OH 43017 ©2025 Cardinal Health CIN 5516034 REV. 09/25", "Other information": "Keep tightly closed, away from excessive heat.", "INACTIVE INGREDIENT": "none", "principal display panel": "LEADER ™ NDC 70000-0024-1 Castor Oil USP Stimulant Laxative 100% Money Back Guarantee For the Relief of Occasional Constipation 4 FL OZ (118 mL) DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING.", "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": "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": "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: 2026-02-15T12:08:28.918463 · Updated: 2026-03-14T23:12:42.073607