FDA Label for Minica-s
View Indications, Usage & Precautions
Minica-s Product Label
The following document was submitted to the FDA by the labeler of this product Sato Pharmaceutical Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient Glycerin 80%
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
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