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Sankaijo (Sato Pharmaceutical Co., Ltd.)

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TABLET 1 BOTTLE in 1 CARTON (49873-404-01) > 150 TABLET in 1 BOTTLE Label Information

Complete Sankaijo Information

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)
    Docusate sodium 8.33mg
    Sennosides 1.36mg


  • PURPOSE

    Purposes
    Docusate sodium    Stool softener laxative
    Sennosides    Stimulant laxative


  • INDICATIONS & USAGE

    Uses
    â– for the relief of occasional constipation (irregularity)
    â– generally produces bowel movement in 6 to 12 hours


  • WARNINGS

    Warnings

    Do not use laxative products for a period longer than 1 week unless directed by a doctor

    Ask a doctor before use if you have
    â– abdominal pain, nausea, or vomiting
    â– noticed a sudden change in bowel habits that persists over a period of 2 weeks

    Ask a doctor or pharmacist before useif you are presently taking mineral oil

    Stop use and ask a doctor if
    â– you have rectal bleeding or failure to have a bowel movement after use of a laxative (may indicate a serious condition)

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

    Frequent or prolonged use of this preparation may result in dependence on laxatives.


  • DOSAGE & ADMINISTRATION

    Directions
    adults and children 12 years and older  -  take 6 to 12 tablets once or twice a day
    children 6 to under 12 years -  take 5 to 7 tablets once or twice a day
    children 2 to under 6 years  -  take 3 to 5 tablets once or twice a day
    children under 2 years -  consult a doctor
    â– once or twice daily, preferably morning and evening, when needed or as directed by a doctor
    â– start initial dosage with minimum dose, then adjust it to suit to bowel condition


  • OTHER SAFETY INFORMATION

    Other information 
    â– each tablet contains calcium 5 mg


  • INACTIVE INGREDIENT

    Inactive ingredients  caramel, carmellose calcium, cinnamon, dibasic calcium phosphate, FDandC Blue No. 2, fennel, hydroxypropyl methylcellulose, magnesium stearate, mentha oil, microcrystalline cellulose, moutan bark, pharbitis seed, polyoxyethylene (105) polyoxypropylene (5) glycol, silicon dioxide, simethicone, synthetic iron oxide, talc


  • INGREDIENTS AND APPEARANCE
    SANKAIJO 
    docusate sodium, sennosides tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49873-404
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    docusate sodium (UNII: F05Q2T2JA0) (docusate - UNII:M7P27195AG) docusate sodium 8.33 mg
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 1.36 mg
    Inactive Ingredients
    Ingredient Name Strength
    caramel (UNII: T9D99G2B1R)  
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FENNEL (UNII: 557II4LLC3)  
    HYPROMELLOSE 2910 (15000 MPA.S) (UNII: 288VBX44JC)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PAEONIA SUFFRUTICOSA ROOT BARK (UNII: BUG255FE7X)  
    IPOMOEA NIL SEED (UNII: I85W45B4WB)  
    PEG/PPG-105/5 COPOLYMER (UNII: 52901V8XAR)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Color brown (greenish brown) Score no score
    Shape ROUND Size 7mm
    Flavor CINNAMON, MENTHOL Imprint Code SATO;9
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49873-404-01 1 in 1 CARTON 12/20/2002
    1 150 in 1 BOTTLE; 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 12/20/2002
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    Name Address ID/FEI Business Operations
    Sato Pharmaceutical Co., Ltd. 715699133 manufacture(49873-404) , label(49873-404) , pack(49873-404)