Mineral Oil
FDA Label NDC 36800-334

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Top Care (topco Associates Llc) for the product Mineral Oil (NDC 36800-334). 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, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if you have, 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

→ Purpose

→ Uses

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ When Using This Product

→ Stop Use And Ask A Doctor If You Have

→ If Pregnant Or Breast Feeding,

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredient

→ Principal Display Panel

→ Package Label

Active Ingredient

Mineral Oil 100%

Purpose

Lubricant laxative

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 6 to 8 hours

Do Not Use

in children under 12 years of age, pregnant wormen, bedridden patients or aged, or if you have difficulty swallowing
if you are presently taking a stool softener laxative
for longer than 1 week

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

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 Reach Of Children

In case of overdose, get medical help or contact a Poison Control center (1-800-222-1222) 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 under 12 years, consult a doctor