Stool Softener

Manufacturer: Reliable 1 Laboratories LLC | Geri-Care Pharmaceutical Corp
Effective date: 2025-12-02
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 01:19:19

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 take only by mouth 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

• noticed a sudden change in bowel habits that lasts for over 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
take only by mouth
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, purified 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	1
1115005	docusate sodium 100 MG Oral Capsule	SCD	1
1115005	DOSS Sodium 100 MG Oral Capsule	SY	1

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0369618086012	GTIN-13: 0369618086012 EAN-13: 0369618086012 GTIN-12: 369618086012 UPC-A: 369618086012 GTIN storage (14 digits): 00369618086012	401-rel.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69618-086-01	Stool Softener	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69618-086-01	EA - Each	69618-086	ed57a7b6-24b7-4ac3-bbb3-0671c65b527d	1	2025-12-16

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69618-086	69618-086-01

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
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
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	Reliable 1 Laboratories LLC	44fae161-3fc8-64c4-e063-6294a90a1d26	2025-12-02	Warnings	Exact identifier ndc (package): 69618-086-01 ndc (product): 69618-086 ndc11 (package): 69618008601 spl id: 44fae16b-d2fe-bf32-e063-6394a90a74b1 spl set id: 44fae161-3fc8-64c4-e063-6294a90a1d26

Reported adverse events (FAERS/openFDA)#

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