Oil

Oil is an FDA-registered drug product whose active ingredient is MINERAL OIL. It is labelled by Atlantic Biologicals Corp. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 17856-1831, application M007, label effective 20260902. It is one of 11 FDA drug label records sharing the active ingredient MINERAL OIL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing MINERAL OIL are most often described in connection with: relief occasional, constipation irregularity, generally productes, bowel movement. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

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 6 to 12 years of age - 1 to 3 teaspoons (15 mL) in 24 hours children under 6 years of age - do not use, consult a doctor

Warnings Do not use if you have difficulty swallowing in children under 6 years of age if you are pregnant for a period of longer than 1 week if you are bedridden or aged

Adverse reaction Distributed by: Atlantic Biologicals Corp. Miami, FL 33179

FDA lists 11 drug label records with MINERAL OIL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Oil used for?
Use for relief of occasional constipation (irregularity). Generally productes bowel movement in 6 to 8 hours.

Who makes Oil?
Atlantic Biologicals Corp. is the labeler of record for Oil. 11 FDA label records share the active ingredient MINERAL OIL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Oil come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Oil prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing MINERAL OIL?
Yes. 11 FDA drug label records list MINERAL OIL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Oil been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.