Minica-S

Active ingredient Glycerin 80%

Purpose Laxative

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

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.

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 information
■A small amount of liquid will remain in unit.
■Store and use at room temperature.

Inactive ingredients Methylparaben, purified water.

CARTON

MINICA-S
glycerin enema

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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M007	05/01/1994

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

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