Rexall 078.001/078aa

SPL v15

SPL

SPL Set ID a1ca668a-3bf9-46a9-8a4f-5cb61547bb81

Route

ORAL

Published

Effective Date 2025-08-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Castor Oil (1 mL)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-10-23 Until 2025-06-01

Description

Castor oil USP 100%

Purpose

Stimulant laxative

Medication Information

Purpose

Stimulant laxative

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

Adverse Reaction

Distributed By Old East Main Co.

100 Mission Ridge, Goodlettsville, TN 37072

Active Ingredient

Castor oil USP 100%

Other Information

keep tightly closed, away from excessive heat.

Inactive Ingredients

none

Princiapl Panel Display

Since 1903 Rexall™

Castor Oil U.S.P.

Stimulant laxative

For relief of occasional constipation

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

4 FL OZ (118 mL)

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

Adverse Reaction (ADVERSE REACTION)

Distributed By Old East Main Co.

100 Mission Ridge, Goodlettsville, TN 37072

Active Ingredient (Active ingredient)

Castor oil USP 100%

Other Information

keep tightly closed, away from excessive heat.

Inactive Ingredients

none

Princiapl Panel Display (Princiapl panel display)

Since 1903 Rexall™

Castor Oil U.S.P.

Stimulant laxative

For relief of occasional constipation

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

4 FL OZ (118 mL)

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": "mL", "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", "ADVERSE REACTION": "Distributed By Old East Main Co. 100 Mission Ridge, Goodlettsville, TN 37072 ", "Active ingredient": "Castor oil USP 100%", "Other Information": "keep tightly closed, away from excessive heat.", "Inactive Ingredients": "none", "Princiapl panel display": "Since 1903 Rexall™ Castor Oil U.S.P. Stimulant laxative For relief of occasional constipation SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION 4 FL OZ (118 mL)", "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: 2026-02-15T12:06:45.364434 · Updated: 2026-03-14T23:09:41.311223