MINICA-S

MINICA-S is an FDA-registered drug product whose active ingredient is GLYCERIN. It is labelled by Sato Pharmaceutical Co., Ltd. taken by rectal and marketed as a human otc drug product. Identifiers on file: NDC 49873-401, application M007, label effective 20260616. It is one of 37 FDA drug label records sharing the active ingredient GLYCERIN. 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 GLYCERIN are most often described in connection with: relief occasional, consipation irregularily, product generally, produces bowel, movement hour. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses For relief of occasional consipation (irregularily). This product generally produces bowel movement in 1/4 to 1 hour.

Directions ■Adults and children 6 years and over: Use 1 rectal enema containing 8 mL of Glycerin daily or as directed by a doctor. Gently insert stem with tip pointing toward navel. Squeeze unit until nearly all liquid is expelled. Remove tip from rectum. ■Children under 6 years: Ask a doctor.

Warnings For rectal use only Do not use ■for a period of longer than 1 week unless directed by a doctor. Frequent or prolonged use of this preparation may result in dependence on laxatives. 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 ■may cause rectal discomfort or burning sensation. Stop use and ask a doctor if ■you have rectal bleeding or failure to have a bowel movement after use of a laxative. This may indicate a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 37 drug label records with GLYCERIN 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.

What is MINICA-S used for?
Uses For relief of occasional consipation (irregularily). This product generally produces bowel movement in 1/4 to 1 hour.

Who makes MINICA-S?
Sato Pharmaceutical Co., Ltd. is the labeler of record for MINICA-S. 37 FDA label records share the active ingredient GLYCERIN, 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 MINICA-S come in?
administered by rectal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is MINICA-S 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 GLYCERIN?
Yes. 37 FDA drug label records list GLYCERIN 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 MINICA-S been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.