Mineral Oil Heavy Liquid
FDA Label NDC 82645-906

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharma Nobis, Llc for the product Mineral Oil Heavy (NDC 82645-906). 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, warnings, ask a doctor before use if, when using this product discotinue use, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Mineral Oil Heavy

Purpose

Laxative

Use

For relief of occasional constipation or irregularit. Generally produces bowel movement in 6 to 8 hrs.

Warnings

Do not take this product if you have abdominal pain, nausea, vomiting, change in bowel habits persisting more than 2 weeks, rectal bleeding or kidney failure are present, or use for a period of longer than 1 week unless directed by a doctor. Frequent or prolonged use may result in the dependence on laxatives.

Do not administer to infants or young children, bedridden or aged patients unless directed by a doctor.

Ask A Doctor Before Use If

you are currently taking a stool softener laxative.

If pregnant or brest feeding ask a health professional before use.

When Using This Product Discotinue Use

and consult a doctor if there is a failure to have a bowel movement after use.

Keep Out Of Reach Of Children

In case of accidental overdose, seek professional assistance or contact Poison Control Center immediately. In case of eye contact wash gently with water for 15 minutes.

Directions

Adults and children 12 yrs and older: 1 to 2 tablespoonfulls at bedtime.

Children 6 to 12 yrs. of age: 1 to 3 teaspoonfuls at bedtime.

Children under 6 yrs. of age: Consult a doctor before use.

Inactive Ingredient

dl-alpha-tocopherol as a preservative.

Other Information

Keep tightly closed and protect from direct light.

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