Sankaijo

Sankaijo
SPL v11
SPL
SPL Set ID 83c0d52b-f7e2-40b0-a01b-1ccee78f8f1b
Route
ORAL
Published
Effective Date 2016-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (8.33 mg) Sennosides (1.36 mg)
Inactive Ingredients
Cellulose, Microcrystalline Paeonia Suffruticosa Root Bark Ipomoea Nil Seed Peg/ppg-105/5 Copolymer Silicon Dioxide Dimethicone Ferric Oxide Red Talc Caramel Carboxymethylcellulose Calcium Calcium Phosphate, Dibasic, Anhydrous Fd&c Blue No. 2 Fennel Hypromellose 2910 (15000 Mpa.s) Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: SATO;9 Shape: round Color: brown Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2002-12-20

Description

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


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

■for the relief of occasional constipation (irregularity)

■generally produces bowel movement in 6 to 12 hours

Dosage and 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



Description

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

Section 34072-9

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

Section 50565-1

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

Section 50566-9

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)



Section 50568-5

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

Section 50569-3

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

Section 50570-1

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

Section 51727-6

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

Section 51945-4

Section 53414-9

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

Section 55105-1

Purposes

Docusate sodium    Stool softener laxative

Sennosides    Stimulant laxative

Section 55106-9

Active ingredients (in each tablet)

Docusate sodium 8.33mg

Sennosides 1.36mg

Section 60561-8

Other information 

■each tablet contains calcium 5 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

■for the relief of occasional constipation (irregularity)

■generally produces bowel movement in 6 to 12 hours

Dosage and Administration (34068-7)

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



Warnings and Precautions (34071-1)

Warnings

Section 34072-9 (34072-9)

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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)



Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Docusate sodium    Stool softener laxative

Sennosides    Stimulant laxative

Section 55106-9 (55106-9)

Active ingredients (in each tablet)

Docusate sodium 8.33mg

Sennosides 1.36mg

Section 60561-8 (60561-8)

Other information 

■each tablet contains calcium 5 mg


Advanced Ingredient Data


Raw Label Data

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