Oil
FDA Label NDC 17856-1831

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corp. for the product Oil (NDC 17856-1831). 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 disclaimer, active ingredients, purpose, use, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Disclaimer

*This product is not manufactured or distributed by Roberts Pharmaceutical Corp., distributor of Roberts ®Mineral Oil.

Active Ingredients

Mineral oil 99.9%

Purpose

Lubricant laxative

Use

for relief of occasional constipation (irregularity).  Generally productes bowel movement in 6 to 8 hours.

Warnings

Do not use

  • if you have difficulty swallowing
  • in children under 6 years of age
  • if you are pregnant
  • for a period of longer than 1 week
  • if you are bedridden or aged

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

  • presently taking a stool softener laxative
  • taking any other drug.  Take this product 2 or more hours before or after other drugs.

    • Laxatives may affect how other drugs work.

When Using This Product

do not take with meals.  Take only at bedtime.

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 serious condition

If 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. (1-800-222-1222)

Directions

  • do not take with meals
  • take only at bedtime
  • may be taken as a single daily dose or in divided doses

    • adults and children 12 years of age and over - 1 to 3 Tablespoons (15 to 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours

    children 6 to 12 years of age - 1 to 3 teaspoons (15 mL) in 24 hours

    children under 6 years of age - do not use, consult a doctor

Other Information

keep tightly closed.  Protect from sunlight

Inactive Ingredients

mixed tocopherols (added as a stabilizer)

Adverse Reaction

Distributed by:

Atlantic Biologicals Corp.

Miami, FL 33179

Principal Display Panel

NDC 17856-1831-05

MINERAL OIL, U.S.P.

LUBRICANT LAXATIVE

  • For Relief of Occasional Constipation
  • Odorless, Tasteless, Colorless

    • *COMPARE TO ACTIVE INGREDIENT OF ROBERTS ®MINERAL OIL*

    NDC 17856-1831-08

    MINERAL OIL, U.S.P.

    LUBRICANT LAXATIVE

    • For Relief of Occasional Constipation
    • Odorless, Tasteless, Colorless

      • *COMPARE TO ACTIVE INGREDIENT OF ROBERTS ®MINERAL OIL*

* Please review the disclaimer below.