Otc - Active Ingredient
Active ingredient Glycerin 80%
Minica-s
FDA Label NDC 49873-401
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sato Pharmaceutical Co., Ltd. for the product Minica-s (NDC 49873-401). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose Laxative
Indications & Usage
Uses For relief of occasional consipation (irregularily). This product generally produces bowel movement in 1/4 to 1 hour.
Warnings
Warnings
For rectal use only
Otc - Do Not Use
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.
Otc - Ask Doctor
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.
Otc - When Using
When using this product
■may cause rectal discomfort or burning sensation.
Otc - Stop Use
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
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.
Other Safety Information
Other information
■A small amount of liquid will remain in unit.
■Store and use at room temperature.
Inactive Ingredient
Inactive ingredients Methylparaben, purified water.
Package Label.Principal Display Panel
Carton (Minicacart)
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