Stool Softener

Manufacturer: Walgreens
Effective date: 2023-10-09
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-01 21:24:43

Label at a glance#

ProductStool Softener

Active ingredientDOCUSATE SODIUM

Label structure10 sections

Indications and uses

for relief of occasional constipation (irregularity) this product generally produces bowel movement in 12 to 72 hours

Dosage and administration

take softgels with a full glass (8 oz) of water adults and children 12 years and older take 1-3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses. children 6 to under 12 years of age take 1 softgel daily or as directed by a doctor children under 6 years of age ask a doctor

Storage and handling

each softgel contains :sodium 6 mg store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Contacts and useful links#

PhoneLabel contact1-877-753-3935

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

for relief of occasional constipation (irregularity)
this product generally produces bowel movement in 12 to 72 hours

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

stomach pain
nausea
vomiting
a sudden change in bowel habits that lasts over 14 days

Stop use and ask a doctor if

OTC - STOP USE SECTION

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
you need to use a laxative for more than 1 week

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

take softgels with a full glass (8 oz) of water

adults and children 12 years and older

take 1-3 softgels daily or as directed by a doctor.

This dose may be taken as a single daily dose or in divided doses.

children 6 to under 12 years of age

take 1 softgel daily or as directed by a doctor

children under 6 years of age

ask a doctor

Other information

STORAGE AND HANDLING SECTION

each softgel contains:sodium 6 mg
store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red #33*, edible ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 7AM-6PM PST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Phillips® Stool Softener Liquid Gels active ingredient††

Stool Softener

DOCUSATE SODIUM 100 mg / STOOL SOFTENER LAXATIVE

SOFTGELS

Gentle & dependable relief of constipation
Stimulant free

SOFTGELS

This product is not manufactured or distributed by Bayer HealthCare LLC., distributor of Phillips'® Stool Softener Liquid Gels

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0363-5790-30	2023-10-09	C162847	48780-1	f386c649-bf7f-0266-e053-dadaa90a7c1a	Drug Facts
0363-5790-30	2023-01-30	C162847	48780-1	f386c649-bf7f-0266-e053-dadaa90a7c1a	Drug Facts

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Stool Softener
Docusate Sodium
DOCUSATE
D&C RED NO. 33
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SORBITAN
SORBITOL
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0363-5790	0363-5790-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DOCUSATE SODIUM	F05Q2T2JA0	ACTIB
D&C RED NO. 33	9DBA0SBB0L	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SORBITAN	6O92ICV9RU	IACT
SORBITOL	506T60A25R	IACT
TITANIUM DIOXIDE	15FIX9V2JP	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
d4f196e0-1e7b-4b9e-93cb-3a2357705ebe			70d804c3-c6f4-4cde-a0ee-7e2577a99956	2023-10-09	Warnings	Exact identifier spl id: d4f196e0-1e7b-4b9e-93cb-3a2357705ebe spl set id: 70d804c3-c6f4-4cde-a0ee-7e2577a99956

Reported adverse events (FAERS/openFDA)#

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