Castor Oil
Rexall 078.001/078AA Castor Oil
a1ca668a-3bf9-46a9-8a4f-5cb61547bb81
HUMAN OTC DRUG LABEL
Aug 12, 2025
OLD EAST MAIN CO
DUNS: 068331990
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Castor Oil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (1)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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)
INDICATIONS & USAGE SECTION
Use
For relief of occasional constipation (irregularity). Generally produces bowel movement in 6 to 12 hours.
ADVERSE REACTIONS SECTION
ADVERSE REACTION
Distributed By Old East Main Co.
100 Mission Ridge, Goodlettsville, TN 37072
OTC - ASK DOCTOR/PHARMACIST SECTION
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.
OTC - DO NOT USE SECTION
Do not use
for a period longer than 1 week
OTC - ASK DOCTOR SECTION
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
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Castor oil USP 100%
OTC - PURPOSE SECTION
Purpose
Stimulant laxative
WARNINGS SECTION
Warnings
for this product
OTC - STOP USE SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,
ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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
STORAGE AND HANDLING SECTION
Other Information
keep tightly closed, away from excessive heat.
INACTIVE INGREDIENT SECTION
Inactive Ingredients
none