Mineral Oil Liquid
FDA Label NDC 36800-931

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Mineral Oil (NDC 36800-931). 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, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, 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

Mineral oil 99.9%

Purpose

Lubricant laxative

Use

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

Do Not Use

  • if you have difficulty swallowing
  • in children under 6 years of age
  • if you are pregnant
  • for a period longer than 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 a 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 - 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours

    children 6 to under 12 years of age - 1 to 3 teaspoons (5 - 15 mL) maximum 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)

Questions?

1-877-932-7948

Other

Dist. By. topco Assoc. LLC, 150 Northwest Point Blvd., Elk Grove Villiage, IL 60007

(c) Topco Questions? 1-888-423-0139  [email protected]

Made in the US with US and foreign components

Principal Display Panel

Mineral oil usp

lubricant laxative

for relief of occasional constipation

  • odorless
  • tasteless
  • colorless

    • SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

    16 FL OZ (1 PT) 473 mL

    831.000/831AA

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