Castor Oil Liquid
FDA Label NDC 69452-487

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bionpharma Inc. for the product Castor Oil (NDC 69452-487). 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 other, active ingredient, purpose, use, warings, otc - do not use, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Other

Drug Facts

*WARNING: Do not use if Tamper Evident Seal is broken or missing. This product is sealed with either a shrink band around cap imprinted “Sealed For Your Protection” or foil seal under cap.

Distributed by: Bionpharma Inc., Princeton, NJ 08540 L0001043 R0425

Active Ingredient

Castor Oil

Purpose

Stimulant Laxative

Use

For temporary relief of occasional constipation. This product generally produces bowel movement in 6 to 12 hours.

Warings

• Frequent or prolonged use may result in the dependence on laxatives.
• Laxative products should not be used for a period longer than 1 week unless directed by a doctor.

Otc - Do Not Use

Do not use when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

Otc - Ask Doctor

Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks.

Otc - Stop Use

Stop use and consult a doctor if you have rectal bleeding or failure to have a bowel movement after the use of a laxative. These symptoms may indicate a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding ask a health professional before use.

Directions

Preferably take on an empty stomach. May be taken with juice to improve taste.

  • Adults and children 12 yrs. of age and older: 15 to 60 milliliters in a single daily dose or as directed by a doctor.
  • Children 2 to under 12 yrs. of age: 5 to 15 milliliters in a single daily dose or as directed by a doctor.
  • Children under 2 yrs. of age: Consult a doctor before use.

Other Information

Keep tightly closed and away from excessive heat.

Questions Or Comments?

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