MINICA-S

Dosage form: enema
Ingredients: glycerin 80mL in 100mL
Labeler: Sato Pharmaceutical Co., Ltd.
NDC Code: 49873-401

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

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.   

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MINICA-S 
glycerin enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-401
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
glycerin (glycerin) glycerin80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
methylparaben 
water 
Packaging
#Item CodePackage Description
1NDC:49873-401-012 APPLICATOR (APPLICATOR) in 1 CARTON
18 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/01/1994
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIOperations
Sato Pharmaceutical Co., Ltd.715699133manufacture, label, pack

Revised: 01/2012
 
Sato Pharmaceutical Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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