Stool Softener

Manufacturer: Geri-Care Pharmaceutical Corp
Effective date: 2023-10-19
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 23:57:01

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, 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 • 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 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

• 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, 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
• 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, sorbitol special, water.

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	4
1115005	docusate sodium 100 MG Oral Capsule	SCD	4
1115005	DOSS Sodium 100 MG Oral Capsule	SY	4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57896-401-01	2020-09-29	C162847	48780-1	9855d018-d802-cd31-e053-dbdaa90ab51a	gc 401
57896-401-03	2020-09-29	C162847	48780-1	9855d018-d802-cd31-e053-dbdaa90ab51a	gc 401
57896-401-10	2020-09-29	C162847	48780-1	9855d018-d802-cd31-e053-dbdaa90ab51a	gc 401
57896-401-25	2020-09-29	C162847	48780-1	9855d018-d802-cd31-e053-dbdaa90ab51a	gc 401
57896-401-01	2019-11-27	C162847	48780-1	9855d018-d802-cd31-e053-dbdaa90ab51a	gc 401
57896-401-03	2019-11-27	C162847	48780-1	9855d018-d802-cd31-e053-dbdaa90ab51a	gc 401
57896-401-10	2019-11-27	C162847	48780-1	9855d018-d802-cd31-e053-dbdaa90ab51a	gc 401
57896-401-25	2019-11-27	C162847	48780-1	9855d018-d802-cd31-e053-dbdaa90ab51a	gc 401

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57896-401-01	Stool Softener	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100	4
57896-401-03	Stool Softener	30 in 1 BOTTLE	CAPSULE, LIQUID FILLED	30	4
57896-401-10	Stool Softener	1000 in 1 BOTTLE	CAPSULE, LIQUID FILLED	1000	4
57896-401-20	Stool Softener	200 in 1 BOTTLE	CAPSULE, LIQUID FILLED	200	4
57896-401-25	Stool Softener	250 in 1 BOTTLE	CAPSULE, LIQUID FILLED	250	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57896-401	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [GERI-CARE PHARMACEUTICAL CORP]	4	Current NDC, Legacy NDC, 5 package rows	20231020_644d81ec-d38f-4172-a087-727b94e2fefe.zip

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	1
DOCUSATE	ACTIVE MOIETY	M7P27195AG	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

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
GLYCERIN
POLYETHYLENE GLYCOL 400
SORBITOL
WATER
FD&C YELLOW NO. 6
MANNITOL
DOCUSATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57896-401	57896-401-10, 57896-401-01, 57896-401-03, 57896-401-20, 57896-401-25

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	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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 420 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GELATIN	GELATIN	2G86QN327L	CAPSULE, LIQUID FILLED / ORAL		1042 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+route 120 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE, DELAYED RELEASE / ORAL		2043 mg	Exact identifier — unii+route 156 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL		1072 mg	Exact identifier — unii+route 120 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, FOR SUSPENSION / ORAL		7621 mg	Exact identifier — unii+route 156 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii+route 108 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii+route 108 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	ELIXIR / ORAL		9306 mg	Exact identifier — unii+route 120 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		616 mg	Exact identifier — unii+route 156 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE, COATED PELLETS / ORAL		14 mg	Exact identifier — unii+route 156 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER, FOR SUSPENSION / ORAL		7093 mg	Exact identifier — unii+route 156 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii+route 120 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION / ORAL		869 mg	Exact identifier — unii+route 156 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii+route 108 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER, FOR SOLUTION / ORAL		3767 mg	Exact identifier — unii+route 156 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE, EXTENDED RELEASE / ORAL		160 mg	Exact identifier — unii+route 156 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, COATED / ORAL	12.96 mg		Exact identifier — unii+route 108 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii+route 120 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii+route 108 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii+route 108 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	GRANULE / ORAL		1328 mg	Exact identifier — unii+route 156 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, DELAYED RELEASE / ORAL		639 mg	Exact identifier — unii+route 156 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route 120 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii+route 120 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii+route 120 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii+route 108 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 mg	Exact identifier — unii+route 108 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii+route 120 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, LIQUID FILLED / ORAL		1042 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, FOR SUSPENSION / ORAL		7621 mg	Exact identifier — unii+route 156 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 120 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii+route 120 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii+route 120 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER, FOR SOLUTION / ORAL		3767 mg	Exact identifier — unii+route 156 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route 120 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, COATED / ORAL	12.96 mg		Exact identifier — unii+route 108 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, COATED / ORAL	177.7 mg		Exact identifier — unii+route 156 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, DELAYED RELEASE / ORAL		639 mg	Exact identifier — unii+route 156 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, ORALLY DISINTEGRATING / ORAL		4364 mg	Exact identifier — unii+route 156 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	GRANULE, FOR SUSPENSION / ORAL		6000 mg	Exact identifier — unii+route 156 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE, EXTENDED RELEASE / ORAL		160 mg	Exact identifier — unii+route 156 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii+route 120 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL		1111 mg	Exact identifier — unii+route 108 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, FOR SUSPENSION / ORAL		7621 mg	Exact identifier — unii+route 156 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii+route 108 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, LIQUID FILLED / ORAL		1122 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii+route 108 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, COATED / ORAL	177.7 mg		Exact identifier — unii+route 156 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii+route 120 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	ELIXIR / ORAL	833.3 mg		Exact identifier — unii+route 108 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, COATED / ORAL	177.7 mg		Exact identifier — unii+route 156 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii+route 120 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii+route 120 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION / ORAL		869 mg	Exact identifier — unii+route 156 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii+route 108 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii+route 108 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	ELIXIR / ORAL	833.3 mg		Exact identifier — unii+route 108 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii+route 108 equally ranked IID candidates

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	644d81ec-d38f-4172-a087-727b94e2fefe	2023-10-19	Warnings	Exact identifier ndc (package): 57896-401-03 ndc (package): 57896-401-10 ndc (package): 57896-401-25 ndc (package): 57896-401-20 ndc (package): 57896-401-01 ndc (product): 57896-401 ndc11 (package): 57896040103 ndc11 (package): 57896040110 ndc11 (package): 57896040101 ndc11 (package): 57896040120 ndc11 (package): 57896040125 spl id: 08173bad-d29e-d916-e063-6394a90a609f spl set id: 644d81ec-d38f-4172-a087-727b94e2fefe

Reported adverse events (FAERS/openFDA)#

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