Stool Softener

Manufacturer: Bryant Ranch Prepack
Effective date: 2022-02-14
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-01 22:07:04

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 and older: take 1-3 softgels daily until first bowel movement; 1 softgel daily thereafter, or as directed by a doctor • children under 12: consult 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 • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool Softener Laxative

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

• have a sudden change in bowel habits that persists over a period of 2 weeks

• are presently taking mineral oil

Stop use and ask a doctor if

• you need to use a laxative longer than 1 week

• you have rectal bleeding or fail to have a bowel movement. These

could be signs of a serious condition.

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 and older: take 1-3
softgels daily until first bowel movement; 1 softgel
daily thereafter, or as directed by a doctor
• children under 12: consult 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
• Tamper Evident: Do not use if imprinted seal
under cap is missing or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerin, PEG, sorbitol special, water.

HOW SUPPLIED

How Supplied Section

NDC: 71335-0937-1: 60 Tablets in a BOTTLE

NDC: 71335-0937-2: 90 Tablets in a BOTTLE

NDC: 71335-0937-3: 18 Tablets in a BOTTLE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DOCUSATE SODIUM 100 MG CAPSULE

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57896-401-01	EA - Each	57896-401	da8e6844-b6ae-4244-8bfc-f7ad99d8eaf8	1	2013-06-04
57896-401-03	EA - Each	57896-401	6762957d-d7f6-4213-a664-2c7f42fc9f36	1	2013-06-04
57896-401-10	EA - Each	57896-401	7ae1d03c-6162-4398-b8d2-1946db28e941	1	2013-06-04
57896-401-20	EA - Each	57896-401	8f701acd-94d7-43d2-9072-f8fbf72510af	1	2021-02-05
57896-401-25	EA - Each	57896-401	5c82cab7-f225-43ff-b3f5-38f5ffd4b01a	1	2018-11-06

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Stool Softener
Docusate Sodium
FD&C RED NO. 40
GELATIN, UNSPECIFIED
GLYCERIN
POLYETHYLENE GLYCOL 400
SORBITOL
WATER
FD&C YELLOW NO. 6
MANNITOL
DOCUSATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71335-0937	71335-0937-1, 71335-0937-2, 71335-0937-3
57896-401

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FD&C RED NO. 40	WZB9127XOA	IACT
GELATIN, UNSPECIFIED	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
SORBITOL	506T60A25R	IACT
WATER	059QF0KO0R	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
MANNITOL	3OWL53L36A	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener	DOCUSATE SODIUM	Geri-Care Pharmaceutical Corp	644d81ec-d38f-4172-a087-727b94e2fefe	2023-10-19	Warnings	Exact identifier ndc (product): 57896-401
2f3614dc-6640-410d-ac43-19559bdb6e7c			8df57c5e-ddea-47d0-bfdd-c625ea2e186d	2022-09-19	Warnings	Exact identifier spl set id: 8df57c5e-ddea-47d0-bfdd-c625ea2e186d

Reported adverse events (FAERS/openFDA)#

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