Mineral Oil Heavy

Mineral Oil Heavy is an FDA drug label for the active ingredient MINERAL OIL manufactured by Pharma Nobis, LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231222.

Generic: MINERAL OIL

Manufacturer: Pharma Nobis, LLC

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 82645-906

Application: M007

Effective: 20231222

Active Ingredients: Active ingredient Mineral Oil Heavy

Indications & Usage

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

Dosage & Administration

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.

Contraindications

Not available.

Warnings

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.

Adverse Reactions

Not available.

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