Stool Softener

Manufacturer: Geri-Care Pharmaceutical Corp
Effective date: 2023-11-15
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:02:15

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

adults and children 12 years and older: take 1 softgel daily or as directed by a doctor children under 12: do not use do not exceed recommended dose

Storage and handling

each softgel contains: sodium 15 mg store at 59°-77°F (15°-25°C) keep tightly closed product of Romania Package not child resistant Tamper Evident: Do not use if imprinted seal under cap is missing or broken

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 250 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
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

adults and children 12 years and older: take 1 softgel daily or as directed by a doctor
children under 12: do not use
do not exceed recommended dose

Other information

STORAGE AND HANDLING SECTION

each softgel contains: sodium 15 mg
store at 59°-77°F (15°-25°C)
keep tightly closed
product of Romania
Package not child resistant
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, glycerol, PEG, purified water, sorbitol special

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
1245468	docusate sodium 250 MG Oral Capsule	PSN	4
1245468	docusate sodium 250 MG Oral Capsule	SCD	4
1245468	DOSS Sodium 250 MG Oral Capsule	SY	4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57896-426-01	2022-11-30	C162847	48780-1	d6a99b39-6659-a426-e053-dadaa90af4c2	gc425 (426)
57896-426-01	2022-01-28	C162847	48780-1	d6a99b39-6659-a426-e053-dadaa90af4c2	gc425 (426)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57896-426-01	Stool Softener	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57896-426	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [GERI-CARE PHARMACEUTICAL CORP]	4	Current NDC, Legacy NDC, 1 package rows	20231116_b595063a-5fee-18c2-e053-2a95a90a5b99.zip

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
GELATIN
GLYCERIN
FD&C YELLOW NO. 6
FOOD YELLOW 3 FREE ACID
WATER
FD&C RED NO. 40
POLYETHYLENE GLYCOL, UNSPECIFIED
DOCUSATE
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57896-426	57896-426-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
WATER	059QF0KO0R	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
DOCUSATE SODIUM	F05Q2T2JA0	ACTIB
SORBITOL	506T60A25R	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
Stool Softener	DOCUSATE SODIUM	Geri-Care Pharmaceutical Corp	b595063a-5fee-18c2-e053-2a95a90a5b99	2023-11-15	Warnings	Exact identifier ndc (package): 57896-426-01 ndc (product): 57896-426 ndc11 (package): 57896042601 spl id: 0a34593a-4c33-3ddd-e063-6394a90a58c1 spl set id: b595063a-5fee-18c2-e053-2a95a90a5b99

Reported adverse events (FAERS/openFDA)#

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