Mineral Oil
FDA Label NDC 11344-831

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 Mineral Oil (NDC 11344-831). 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, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, 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

for this product

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 wrok.

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

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: Vi-Jon

One Swan Drive

Smyrna, TN 37167

Principal Display Panel

SWAN

MINERAL OIL

U.S.P. LUBRICANT LAXATIVE

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

    • COMPARE TO ACTIVE INGREDIENT OF ROBERTS ®MINERAL OIL*

    SEALED WITH PRINTED FOIL CAP FOR YOUR PROTECTION

    16 FL OZ (1 PT) 473 mL

    Image Description (Mm01)

    Image Description (Mm01)

* Please review the disclaimer below.