Label: SANKAIJO- docusate sodium, sennosides tablet
- NDC Code(s): 49873-404-01
- Packager: Sato Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 29, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
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 weeksStop 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)
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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
■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 SAFETY INFORMATION
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SANKAIJO
docusate sodium, sennosides tabletProduct 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 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 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 Drug M007 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)
