Dulcolax Stool Softener

Manufacturer
Chattem, Inc.
Effective date
2020-11-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:09:23

Label at a glance#

ProductDulcolax Stool Softener
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Dosage and administration

take with a glass of water adults and children 12 years of age and over       1 to 3 capsules daily. This dose 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 of age                               ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Dulcolax® Stool Softener

Drug Facts

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium (USP) 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Use

INDICATIONS & USAGE SECTION

● for relief of occasional constipation and irregularity

● this product generally produces bowel movement in 12 to 72 hours

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

● if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

● stomach pain, nausea or vomiting

● a sudden change in bowel habits that lasts more than 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

● you have rectal bleeding or no bowel movement after using this product. 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 with a glass of water

adults and children 12 years of age and over       1 to 3 capsules daily. This dose 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 of age                               ask a doctor

Other information

SPL UNCLASSIFIED SECTION

● each capsule contains: sodium 6 mg

● store at 20°-25°C (68°-77°F)

● protect from excessive humidity

● do not use this product if the safety seal under the cap is torn or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, propylene glycol, sorbitan, sorbitol, water

Questions?

OTC - QUESTIONS SECTION

Call 1- 866-844-2798 or visit www.Dulcolax.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dulcolax
Docusate sodium (USP) 100 mg/ Stool Softener Laxative
STOOL SOFTENER
STIMULANT-FREE
50
LIQUID GELS
Sugar Free

Dulcolax Docusate sodium (USP) 100 mg/ Stool Softener Laxative STOOL SOFTENER STIMULANT-FREE 50 LIQUID GELS Sugar FreeDulcolax Docusate sodium (USP) 100 mg/ Stool Softener Laxative STOOL SOFTENER STIMULANT-FREE 50 LIQUID GELS Sugar Free

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-0220-2EA - Each41167-0220bc7e279a-9959-4b39-90e2-0b510a71e62e12022-06-06

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41167-022041167-0220-5, 41167-0220-4, 41167-0220-2, 41167-0220-3, 41167-0220-9, 41167-0220-6

Ingredients#

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

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

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
59520d68-6e11-4cd5-80d6-1e4fdbfacf7b5c382fcc-a5e8-40f9-b5ae-5ed7a060b8982021-03-08WarningsExact identifier
spl set id: 5c382fcc-a5e8-40f9-b5ae-5ed7a060b898

Reported adverse events (FAERS/openFDA)#

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