Laxative Docusate Sodium With Senna

Laxative Docusate Sodium With Senna
SPL v3
SPL
SPL Set ID cf9075d8-e20e-419a-b996-9b12f49f05f2
Route
ORAL
Published
Effective Date 2025-01-02
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 Blue No. 2 Aluminum Lake Fd&c Red No. 40 Aluminum Lake Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: S154 Shape: round Color: red 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 Stimulant laxative


Medication Information

Purpose

Stool softener Stimulant 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 COLACE® 2-IN-1 ACTIVE INGREDIENTS*

Stool Softener + Stimulant Laxative

For Relief Of Occasional Constipation:

• Effective

• Reliable

• Comfortable

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 Colace® 2-IN-1.

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

KEEP OUTER CARTON FOR COMPLETE PRODUCT INFORMATION

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

Stimulant 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 only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.

adults and children 12 years and over take 2-4 tablets daily
children 6 to under 12 years of age take 1-2 tablets daily
children 2 to under 6 years of age take up to 1 tablet daily
children under 2 years 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 blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, 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 COLACE® 2-IN-1 ACTIVE INGREDIENTS*

Stool Softener + Stimulant Laxative

For Relief Of Occasional Constipation:

• Effective

• Reliable

• Comfortable

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 Colace® 2-IN-1.

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

KEEP OUTER CARTON FOR COMPLETE PRODUCT INFORMATION

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

Stimulant 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 only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.

adults and children 12 years and over take 2-4 tablets daily
children 6 to under 12 years of age take 1-2 tablets daily
children 2 to under 6 years of age take up to 1 tablet daily
children under 2 years 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 blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, 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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