Stool Softener

Manufacturer: KROGER COMPANY | Geri-Care Pharmaceutical Corp
Effective date: 2023-10-23
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 23:57:27

Label at a glance#

ProductStool Softener

Active ingredientDOCUSATE SODIUM

Label structure8 sections

Indications and uses

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

Dosage and administration

Take only by mouth. Adults and children 12 years of age and older 1 to 3 capsules daily. May be taken as a single daily dose or in divided doses. Children 2 to under 12 years of age 1 capsule daily Children under 2 years 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 • product of Romania • 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 lasts longer than 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

Take only by mouth.

Adults and children 12 years of age and older	1 to 3 capsules daily. May be taken as a single daily dose or in divided doses.
Children 2 to under 12 years of age	1 capsule daily
Children under 2 years	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

• product of Romania

• Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

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
30142-407-01	2022-11-17	C162847	48780-1	d6a99b39-e336-a426-e053-dadaa90af4c2	kro 406
30142-407-01	2022-01-28	C162847	48780-1	d6a99b39-e336-a426-e053-dadaa90af4c2	kro 406

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
30142-407-01	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
30142-407	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [KROGER COMPANY]	4	Current NDC, Legacy NDC, 1 package rows	20231024_a1afaa71-7e8c-5a49-e053-2a95a90a4db0.zip

Products#

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

DailyMed product names page 1 of 1 · 13 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
MANNITOL
DOCUSATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
30142-407	30142-407-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener	DOCUSATE SODIUM	KROGER COMPANY	a1afaa71-7e8c-5a49-e053-2a95a90a4db0	2023-10-23	Warnings	Exact identifier ndc (package): 30142-407-01 ndc (product): 30142-407 ndc11 (package): 30142040701 spl id: 08649f4b-9276-f53f-e063-6394a90a023a spl set id: a1afaa71-7e8c-5a49-e053-2a95a90a4db0

Reported adverse events (FAERS/openFDA)#

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