cvs

cvs
SPL v2
SPL
SPL Set ID 2881d83d-9929-677a-e063-6394a90a0424
Route
oral
Published
Effective Date 2025-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
docusate (50 mg) sennosides (8.6 mg)
Inactive Ingredients
yellow wax silicon dioxide d&c red no. 33 fd&c red no. 40 fd&c yellow no. 6 gelatin, unspecified glycerin light mineral oil povidone, unspecified water carboxymethylcellulose sodium, unspecified sorbitol sorbitan soybean lecithin titanium dioxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-03-19

Purpose

Stool softener Stimulant laxative

Description

Docusate sodium 50 mg Sennosides 8.6 mg


Medication Information

Warnings

Do not use

• laxative products for longer than 1 week unless told to do so by a doctor 

• if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

• stomach pain • nausea • vomiting

• noticed a sudden change in bowel habits that lasts over 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 could be signs of a serious condition.

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

Uses

• relieves occasional constipation (irregularity)

• generally produces bowel movement in 6 to 12 hours

Purpose

Stool softener

Stimulant laxative

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 softgels daily
 children 6 to under 12 years of age take 1-2 softgels daily
 children under 6 years of age ask a doctor

Other Information

• each softgel contains: sodium 4 mg

• store at room temperature between 20°-25°C (68°-77°F)

Inactive Ingredients

beeswax, colloidal silicon dioxide, D&C Red No. 33, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, light liquid paraffin, povidone, purified water, sodium carboxymethyl cellulose, sorbitol sorbitan solution, soy lecithin, titanium dioxide

Description

Docusate sodium 50 mg Sennosides 8.6 mg

Section 42229-5

Compare to the active ingredients in COLACE® 2-IN-1*

Liquid Filled Softgels

Package Contains One Bottle

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION.

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

Product of India

*This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., owner of the registered trademark COLACE® 2-IN-1.

Section 50565-1

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

Packaging

Drug Facts

Questions Or Comments?

Call 1-800-SHOP-CVS

Active Ingredients (in Each Softgel)

Docusate sodium 50 mg

Sennosides 8.6 mg


Structured Label Content

Warnings

Do not use

• laxative products for longer than 1 week unless told to do so by a doctor 

• if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

• stomach pain • nausea • vomiting

• noticed a sudden change in bowel habits that lasts over 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 could be signs of a serious condition.

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

Uses

• relieves occasional constipation (irregularity)

• generally produces bowel movement in 6 to 12 hours

Purpose

Stool softener

Stimulant laxative

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 softgels daily
 children 6 to under 12 years of age take 1-2 softgels daily
 children under 6 years of age ask a doctor

Other Information (Other information)

• each softgel contains: sodium 4 mg

• store at room temperature between 20°-25°C (68°-77°F)

Inactive Ingredients (Inactive ingredients)

beeswax, colloidal silicon dioxide, D&C Red No. 33, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, light liquid paraffin, povidone, purified water, sodium carboxymethyl cellulose, sorbitol sorbitan solution, soy lecithin, titanium dioxide

Section 42229-5 (42229-5)

Compare to the active ingredients in COLACE® 2-IN-1*

Liquid Filled Softgels

Package Contains One Bottle

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION.

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

Product of India

*This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., owner of the registered trademark COLACE® 2-IN-1.

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.

Packaging

Drug Facts

Questions Or Comments? (Questions or comments?)

Call 1-800-SHOP-CVS

Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))

Docusate sodium 50 mg

Sennosides 8.6 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)