MedPath

Castor Oil

CVS 078.000/078AA Castor Oil

Approved
Approval ID

f20de8f2-3637-4485-8b80-0a12fd5e651c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 1, 2025

Manufacturers
FDA

CVS Pharmacy

DUNS: 062312574

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
NDC Product Code69842-978
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
Castor Oil
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (1)

CASTOR OILActive
Quantity: 1 mg in 1 mL
Code: D5340Y2I9G
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/1/2025

principal display panel

CVS Health ®

Castor Oil USP

STIMULANT LAXATIVE

For relief of occasional constipation

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

4 FL OZ (118 mL)

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/1/2025

Use

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

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 8/1/2025

ADVERSE REACTION

Distributed by: CVS Pharmacy, Inc

One CVS Drive, Woonsocket, RI 02895

©2024 CVS/pharmacy V-39962

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/1/2025

Active ingredient

Castor oil USP 100%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/1/2025

Purpose

Stimulant laxative

WARNINGS SECTION

LOINC: 34071-1Updated: 8/1/2025

Warnings

for this product

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/1/2025

Do not use

for a period longer than 1 week

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 8/1/2025

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 - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 8/1/2025

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 - STOP USE SECTION

LOINC: 50566-9Updated: 8/1/2025

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

LOINC: 53414-9Updated: 8/1/2025

If pregnant or breast-feeding,

ask a help professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/1/2025

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/1/2025

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

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 8/1/2025

Other information

Keep tightly closed, away from excessive heat

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/1/2025

Inactive Ingredients

None

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