Rexall 078.001/078AA

Manufacturer
Old East Main Co. | Nice-Pak Products, LLC
Effective date
2026-03-12
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 01:54:28

Label at a glance#

ProductCastor Oil
Active ingredientCASTOR OIL
Label structure15 sections

Dosage and administration

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

keep tightly closed, away from excessive heat.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Castor oil USP 100%

Purpose

OTC - PURPOSE SECTION

Stimulant laxative

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

for this product

Do not use

OTC - DO NOT USE SECTION

for a period longer than 1 week

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other drug.  Take this product 2 or more hours before or after other drugs.  Laxatives may affect how other drugs work.

Stop use and ask a doctor

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other Information

STORAGE AND HANDLING SECTION

keep tightly closed, away from excessive heat.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

none

ADVERSE REACTION

ADVERSE REACTIONS SECTION

Distributed By Old East Main Co.

100 Mission Ridge, Goodlettsville, TN 37072 

Princiapl panel display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

image descriptionimage descriptionimage descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData MatrixL0021000BAmm02.jpg
Data codeData MatrixL0021000FAmm01.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55910-979-262020-06-23C16284748780-19d75b9d0-1ced-f424-e053-dadaa90a57ceRexall 078.001/078AA Castor Oil
55910-979-262020-01-31C16284748780-19d75b9d0-1ced-f424-e053-dadaa90a57ceRexall 078.001/078AA Castor Oil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-979-16Castor Oil59 mL in 1 BOTTLE, PLASTICLIQUID5916
55910-979-26Castor Oil118 mL in 1 BOTTLE, PLASTICLIQUID11816

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-97955910-979-26, 55910-979-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
CASTOR OILD5340Y2I9GACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Castor OilCASTOR OILOld East Main Co.a1ca668a-3bf9-46a9-8a4f-5cb61547bb812026-03-12Warnings, Adverse reactionsExact identifier
ndc (package): 55910-979-16
ndc (package): 55910-979-26
ndc (product): 55910-979
ndc11 (package): 55910097926
ndc11 (package): 55910097916
spl id: 4c0ede5f-ea72-3b48-e063-6394a90a9c7d
spl set id: a1ca668a-3bf9-46a9-8a4f-5cb61547bb81

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.