Stool Softener

Manufacturer: HEB | Geri-Care Pharmaceutical Corp
Effective date: 2025-12-08
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:20:52

Label at a glance#

ProductStool Softener

Active ingredientDOCUSATE SODIUM

Label structure9 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

Dosage and administration

• do not exceed recommended dose • adults and children 12 years of age and older: take 1-3 softgels daily, usually 1 softgel daily after the first bowel movement, or as directed by a doctor • children under 12: ask a doctor

Storage and handling

• each softgel contains: sodium 7 mg. very low sodium • store at 59°-77°F (15°-25°C) • keep tightly closed

Contacts and useful links#

PhoneLabel contact1-800-540-3765

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool Softener

Uses

INDICATIONS & USAGE SECTION

relieves occasional constipation (irregularity)

generally produces bowel movement in 12 to 72 hours

Warnings

WARNINGS SECTION

Ask a doctor before use if you

• have stomach pain, nausea or vomiting

• noticed a sudden change in bowel habits that lasts longer than 2 weeks

• are presently taking mineral oil

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition.

• you need to use a laxative longer than 1 week

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• do not exceed recommended dose
• adults and children 12 years of age and older: take 1-3
softgels daily, usually 1 softgel daily after the first bowel movement, or as directed by a doctor
• children under 12: ask a doctor

Other information

STORAGE AND HANDLING SECTION

• each softgel contains: sodium 7 mg. very low sodium

• store at 59°-77°F (15°-25°C)

• keep tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

gelatin (bovine), glycerin, polyethylene glycol, purified water, sorbitol. Contains less that 1% of D&C red #33, edible ink, FD&C red #40, FD&C yellow #6 (sunset yellow), titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1115005	docusate sodium 100 MG Oral Capsule	PSN	2
1115005	docusate sodium 100 MG Oral Capsule	SCD	2
1115005	DOSS Sodium 100 MG Oral Capsule	SY	2

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	ITF	01267373		406heb.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
37808-582-01	Stool Softener	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100		2
37808-582-01	Stool Softener	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1		2

Products#

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

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

Stool Softener
Docusate Sodium
TITANIUM DIOXIDE
D&C RED NO. 33
POLYETHYLENE GLYCOL 400
FD&C RED NO. 40
GELATIN
GLYCERIN
SORBITOL
WATER
FD&C YELLOW NO. 6
DOCUSATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37808-582	37808-582-01

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
TITANIUM DIOXIDE	15FIX9V2JP	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
SORBITOL	506T60A25R	IACT
WATER	059QF0KO0R	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
DOCUSATE SODIUM	F05Q2T2JA0	ACTIB

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
Stool Softener	DOCUSATE SODIUM	HEB	2f10041a-8c88-09a5-e063-6294a90a07cc	2025-12-08	Warnings	Exact identifier ndc (package): 37808-582-01 ndc (product): 37808-582 ndc11 (package): 37808058201 spl id: 4576eb34-9199-8cf6-e063-6394a90ae2c3 spl set id: 2f10041a-8c88-09a5-e063-6294a90a07cc

Reported adverse events (FAERS/openFDA)#

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