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

Description

Castor oil USP 100%

Purpose

Stimulant Laxative

Adverse Reactions

Medication Information

Purpose

Stimulant Laxative

Adverse Reactions

Dist. by CAH, Dublin, OH 43017

CIN 5516034 REV. 09/25

Description

Castor oil USP 100%

Use

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

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%

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.

Structured Label Content

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 (Do not use)

for a period longer than 1 week

Questions?

1-888-593-0593

Active Ingredient (Active ingredient)

Castor oil USP 100%

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.

Inactive Ingredient (INACTIVE INGREDIENT)

none

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.

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