Mineral Oil
FDA Label NDC 54162-190

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Llc for the product Mineral Oil (NDC 54162-190). 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:, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor, if pregnant or breast feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Mineral Oil 99.99%

Purpose:

Lubricant Laxative

Uses

For relief of occasional constipation (irregularity)

generally produces 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 longer than one 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 of pharmamcist 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 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 Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out Of The Reach Of Children

In case of accidental 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

    • Age                                                      Dose

    adults and children over 12 years         1 to 3 tablespoons (15 to 45 ml)

                                                              maximum 3 tablespoons (45mL) in 24 hours

    children 6 years to under 12 years         1 to 3 teaspoons(15 to 45 ml)

                                                              maximum 3 teaspoons (45mL) in 24 hours

    Children under 6 years                           Do not use, consult a doctor

Other Information

Keep tightly closed. Protect from sunlight. For more info call 800-736-3437

Inactive Ingredients

Mixed tocopherols (added as a stabilizer)

Principal Display Panel

Geritrex

Mineral Oil

USP

Lubricant Laxative

Odorless

Tasteless

Colorless

16 OZ (472 ml)

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