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  5. Label Information: Sankaijo

FDA Label for Sankaijo

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - STOP USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. GENERAL PRECAUTIONS
    12. DOSAGE & ADMINISTRATION
    13. OTHER SAFETY INFORMATION
    14. INACTIVE INGREDIENT
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sankaijo Product Label

The following document was submitted to the FDA by the labeler of this product Sato Pharmaceutical Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



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


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

Carton - sankaijocart


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