Castor Oil Liquid
FDA Label NDC 11344-078

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nice-pak Products, Llc for the product Castor Oil (NDC 11344-078). 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 if you are, 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

Active Ingredient

Castor oil USP 100%

Purpose

Stimulant laxative

Use

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

Warnings

Warnings

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 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.

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

Distributed by: Vi-Jon

8515 Page Ave.

St. Louis, MO 63114

Principal Display Panel

NDC 11344-078-26

GoodSense

Castor Oil USP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Stimulant laxative

4 FL OZ (118 mL)

Image Description (Mm01)

Image Description (Mm01)

078.000/078AA

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