Active Ingredient
Castor Oil USP 100%
Castor Oil Liquid
FDA Label NDC 0869-0078
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vi-jon, Llc for the product Castor Oil (NDC 0869-0078). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stimulant laxative
Use
For relief of occasional constipation (iregularity). Generally produces bowel movement in 6 to 12 hours
Warnings
for this product
Do Not Use
For a period longer than 1 week
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.
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 help professional before use.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away
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 Information
Keep tightly closed, away from excessive heat
Other
Vi-Jon
One Swan Drive, Smyrna, TN 37167
078.000/078AA
Principal Display Panel
NDC 0869-0078-26
Swan
Castor Oil
U.S.P. STIMULANT LAXATIVE
For the Relief of Occasional Constipation
DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING
4 FL OZ (118 mL)
Sealed with printed neckband for your protection
mountain falls
castor
oil U.S.P.
stimulant laxative
4 FL OZ (118 mL)
Image Description (Mm02)
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