Product Label

Product Label
SPL v5
SPL
SPL Set ID 40f14e88-015a-455c-82bb-30df683bb55a
Route
ORAL
Published
Effective Date 2025-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Docusate calcium 240 ​mg


Medication Information

Indications and Usage

for relief of occasional constipation (irregularity)  this product generally produces a bowel movement within 12 to 72 hours

Dosage and Administration

adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor children under 12 years of age: ask a doctor

Description

Docusate calcium 240 ​mg

Section 44425-7

store between 20-25ºC (68-77ºF); excursions permitted between 15-30ºC (59-86ºF)

Section 50565-1

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

Section 50566-9

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week

Section 50569-3

stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks

Section 50570-1

if you are currently taking mineral oil, unless directed by a doctor.

Section 51727-6

corn oil, FD & C blue #1, FD & C red #40, FD & C yellow #6, gelatin, glycerin, purified water, sorbitan, sorbitol

Section 51945-4

Compare to the active ingredient in Surfak®† Docusate Calcium 240 mg Stool Softener Laxative Sodium Free Softgels †This product is not manufactured or distributed by Chattem, Inc., distributor of Surfak®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by: MAJOR® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152

Section 53413-1

Call 1-800-616-2471

Section 53414-9

ask a health professional before use.

Section 55105-1

Stool softener laxative

Section 55106-9

Docusate calcium 240 ​mg


Structured Label Content

Indications and Usage (34067-9)

for relief of occasional constipation (irregularity)  this product generally produces a bowel movement within 12 to 72 hours

Dosage and Administration (34068-7)

adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor children under 12 years of age: ask a doctor

Section 44425-7 (44425-7)

store between 20-25ºC (68-77ºF); excursions permitted between 15-30ºC (59-86ºF)

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week

Section 50569-3 (50569-3)

stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks

Section 50570-1 (50570-1)

if you are currently taking mineral oil, unless directed by a doctor.

Section 51727-6 (51727-6)

corn oil, FD & C blue #1, FD & C red #40, FD & C yellow #6, gelatin, glycerin, purified water, sorbitan, sorbitol

Section 51945-4 (51945-4)

Compare to the active ingredient in Surfak®† Docusate Calcium 240 mg Stool Softener Laxative Sodium Free Softgels †This product is not manufactured or distributed by Chattem, Inc., distributor of Surfak®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by: MAJOR® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152

Section 53413-1 (53413-1)

Call 1-800-616-2471

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Stool softener laxative

Section 55106-9 (55106-9)

Docusate calcium 240 ​mg


Raw Label Data

All Sections (JSON)