Stool Softener Laxative

Manufacturer: Major Pharmaceuticals
Effective date: 2025-07-23
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 20:35:38

Label at a glance#

ProductStool Softener Laxative

Active ingredientDOCUSATE CALCIUM

Label structure10 sections

Indications and uses

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

Storage and handling

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

Contacts and useful links#

PhoneLabel contact1-800-616-2471

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate calcium 240 mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-616-2471

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6997-40	EA - Each	0904-6997	4d83e65e-6ef2-4d0d-9a20-46b99ae0b084	1	2021-03-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Stool Softener Laxative
Docusate calcium
DOCUSATE
CORN OIL
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
WATER
SORBITOL
SORBITAN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0904-6997	0904-6997-60, 0904-6997-80, 0904-6997-40

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DOCUSATE CALCIUM	6K7YS503HC	ACTIB
CORN OIL	8470G57WFM	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
SORBITAN	6O92ICV9RU	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
7b1ea5a5-225f-401f-8a65-c00f3dec2c3c			40f14e88-015a-455c-82bb-30df683bb55a	2025-07-23	Warnings	Exact identifier spl id: 7b1ea5a5-225f-401f-8a65-c00f3dec2c3c spl set id: 40f14e88-015a-455c-82bb-30df683bb55a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.