Drug Facts

Manufacturer: ATLANTIC BIOLOGICALS CORP.
Effective date: 2026-06-30
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: weekly-update
Hydrated at: 2026-07-17 21:41:51

Label at a glance#

ProductStool Softener Laxative

Active ingredientDOCUSATE SODIUM

Label structure10 sections

Indications and uses

relieves 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

each softgel contains: sodium 13 mg store between 20-25ºC(68-77ºF); excursions permitted between 15-30ºC (59-86ºF)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-753-3935

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 250 mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Uses

INDICATIONS & USAGE SECTION

relieves 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 presently 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 last 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 (1-800-222-1222) 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

each softgel contains:sodium 13 mg
store between 20-25ºC(68-77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mannitol, mineral oil, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, white ink

Questions?

OTC - QUESTIONS SECTION

Call 1-877-753-3935Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extra Strength

Docusate Sodium

250 mg

Stool Softener Laxative

Softgels

Distributed by:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	Data Matrix	(01)00317856728119(21)XXXXXXXXXXX(10)XXXXXXXXXX(17)010101	GTIN-14: 00317856728119 GTIN-12: 317856728119 UPC-A: 317856728119 EAN-13: 0317856728119 GTIN storage (14 digits): 00317856728119	17856-7281-01 Rev. 2 Case label.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7281-60	EA - Each	0904-7281	b2630097-6a2c-4a41-a669-a69453258fb3	1	2023-07-06
0904-7281-80	EA - Each	0904-7281	ad308384-bdc4-4d4a-a0ce-73bb81d2b060	1	2023-07-06

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Stool Softener Laxative
Docusate Sodium
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SORBITOL
ANHYDROUS CITRIC ACID
ISOPROPYL ALCOHOL
LECITHIN, SOYBEAN
MANNITOL
MINERAL OIL
SORBITAN
DOCUSATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17856-7281	17856-7281-1
0904-7281

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
LECITHIN, SOYBEAN	1DI56QDM62	IACT
MANNITOL	3OWL53L36A	IACT
MINERAL OIL	T5L8T28FGP	IACT
SORBITAN	6O92ICV9RU	IACT
DOCUSATE SODIUM	F05Q2T2JA0	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
2	2025-06-27	full-release	2026-06-01 01:06:08

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener Laxative	DOCUSATE SODIUM	ATLANTIC BIOLOGICALS CORP.	c1f588d0-4600-4b97-b2d3-2c08ac351e07	2026-06-30	Warnings	Exact identifier ndc (package): 17856-7281-1 ndc (product): 17856-7281 ndc11 (package): 17856728101 spl id: 557db047-3bfa-a160-e063-6394a90a6621 spl set id: c1f588d0-4600-4b97-b2d3-2c08ac351e07
Stool Softener Laxative	DOCUSATE SODIUM	Major Pharmaceuticals	93ef6486-0930-41e3-a2c6-44af7e37e98b	2026-03-31	Warnings	Exact identifier ndc (product): 0904-7281

Reported adverse events (FAERS/openFDA)#

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