Otc - Active Ingredient
Active ingredients (in each tablet)
Docusate sodium 8.33mg
Sennosides 1.36mg
Sankaijo Tablet
FDA Label NDC 49873-404
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sato Pharmaceutical Co., Ltd. for the product Sankaijo (NDC 49873-404). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purposes
Docusate sodium Stool softener laxative
Sennosides Stimulant laxative
Indications & Usage
Uses
■for the relief of occasional constipation (irregularity)
■generally produces bowel movement in 6 to 12 hours
Warnings
Warnings
Otc - Do Not Use
Do not use laxative products for a period longer than 1 week unless directed by a doctor
Otc - Ask 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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before useif you are presently taking mineral oil
Otc - Stop Use
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)
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
General Precautions
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
■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
Other information
■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
Package Label.Principal Display Panel
Carton (Sankaijocart)
* Please review the disclaimer below.
