Label: MINICA-S- glycerin enema

  • NDC Code(s): 49873-401-01
  • Packager: Sato Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 7, 2023

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  • 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

    CARTON

  • INGREDIENTS AND APPEARANCE
    MINICA-S 
    glycerin enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-401
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-401-012 in 1 CARTON05/01/1994
    18 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00705/01/1994
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-401) , label(49873-401) , pack(49873-401)
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