Vegetable Laxative And Stool Softner

Vegetable Laxative And Stool Softner
SPL v3
SPL
SPL Set ID e84d693d-0041-4c11-8f6a-b5c332f79af9
Route
ORAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg) Sennosides (8.6 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Anhydrous Dibasic Calcium Phosphate Fd&c Yellow No. 6 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: S153 Shape: round Color: orange Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-01

Description

Docusate sodium 50 mg Sennosides 8.6 mg

Purpose

Stool softener Laxative


Medication Information

Purpose

Stool softener Laxative

Description

Docusate sodium 50 mg Sennosides 8.6 mg

Uses

• relieves occasional constipation (irregularity)

• generally, produces bowel movement in 6 to 12 hours

Section 42229-5

+TopCare®

health

COMPARE TO SENOKOT-S® ACTIVE INGREDIENTS*

Vegetable Laxative + Stool Softener

Gentle Relief of Constipation

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE PRODUCT INFORMATION

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO STVA1120

[email protected]  www.topcarebrand.com

*This product is not manufactured or distributed by Purdue Products L.P., distributor of Senokot-S®.

Section 50565-1

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

Purposes

Stool softener

Laxative

Warnings

Do not use

• if you are now taking mineral oil, unless directed by a doctor

• laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

• stomach pain

• nausea

• vomiting

• noticed a sudden change in bowel habits that continues over a period of 2 weeks

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

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

Packaging

Directions

• take preferably at bedtime or as directed by a doctor

Age Starting Dosage Maximum Dosage
adults and children 12 years and over 2 tablets once a day 4 tablets twice a day
children 6 to under 12 years 1 tablet once a day 2 tablets twice a day
children 2 to under 6 years ½ tablet once a day 1 tablet twice a day
children under 2 years ask a doctor ask a doctor

Drug Facts

Questions?

Call 1-888-423-0139

Other Information

each tablet contains: calcium 20 mg, sodium 3 mg (low sodium)

• store between 20-25°C (68-77°F)

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Active Ingredients (in Each Tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg


Structured Label Content

Uses

• relieves occasional constipation (irregularity)

• generally, produces bowel movement in 6 to 12 hours

Section 42229-5 (42229-5)

+TopCare®

health

COMPARE TO SENOKOT-S® ACTIVE INGREDIENTS*

Vegetable Laxative + Stool Softener

Gentle Relief of Constipation

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE PRODUCT INFORMATION

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO STVA1120

[email protected]  www.topcarebrand.com

*This product is not manufactured or distributed by Purdue Products L.P., distributor of Senokot-S®.

Section 50565-1 (50565-1)

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

Purposes

Stool softener

Laxative

Warnings

Do not use

• if you are now taking mineral oil, unless directed by a doctor

• laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

• stomach pain

• nausea

• vomiting

• noticed a sudden change in bowel habits that continues over a period of 2 weeks

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

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

Packaging

Directions

• take preferably at bedtime or as directed by a doctor

Age Starting Dosage Maximum Dosage
adults and children 12 years and over 2 tablets once a day 4 tablets twice a day
children 6 to under 12 years 1 tablet once a day 2 tablets twice a day
children 2 to under 6 years ½ tablet once a day 1 tablet twice a day
children under 2 years ask a doctor ask a doctor

Drug Facts

Questions?

Call 1-888-423-0139

Other Information (Other information)

each tablet contains: calcium 20 mg, sodium 3 mg (low sodium)

• store between 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Docusate sodium 50 mg

Sennosides 8.6 mg


Advanced Ingredient Data


Raw Label Data

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