SANKAIJO- docusate sodium, sennosides tablet 
Sato Pharmaceutical Co., Ltd.

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Sankaijo

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

Purposes
Docusate sodium    Stool softener laxative
Sennosides    Stimulant laxative

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

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
■abdominal pain, nausea, or vomiting
■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
■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.

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
■once or twice daily, preferably morning and evening, when needed or as directed by a doctor
■start initial dosage with minimum dose, then adjust it to suit to bowel condition

Other information 
■each tablet contains calcium 5 mg

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

Carton

SANKAIJO 
docusate sodium, sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-404
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM8.33 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES1.36 mg
Inactive Ingredients
Ingredient NameStrength
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)  
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)  
Product Characteristics
Colorbrown (greenish brown) Scoreno score
ShapeROUNDSize7mm
FlavorCINNAMON, MENTHOLImprint Code SATO;9
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49873-404-011 in 1 CARTON12/20/2002
1150 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00712/20/2002
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIBusiness Operations
Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-404) , label(49873-404) , pack(49873-404)

Revised: 11/2023
Document Id: 0b54b2d1-83e7-3a18-e063-6394a90a5b58
Set id: 83c0d52b-f7e2-40b0-a01b-1ccee78f8f1b
Version: 11
Effective Time: 20231129
 
Sato Pharmaceutical Co., Ltd.