MINICA-S- glycerin enema

MINICA-S by

Drug Labeling and Warnings

MINICA-S by is a Otc medication manufactured, distributed, or labeled by Sato Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient    Glycerin 80%

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   

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.

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.   

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINICA-S 
glycerin enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49873-401
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49873-401-01	2 in 1 CARTON	05/01/1994
1		8 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	05/01/1994

Labeler - Sato Pharmaceutical Co., Ltd. (690575642)

Establishment
Name	Address	ID/FEI	Business Operations
Sato Pharmaceutical Co., Ltd.		715699133	manufacture(49873-401) , label(49873-401) , pack(49873-401)