FDA.reportPublic FDA data

Medline Docusate Sodium 100 mg Tablets

Manufacturer
Medline Industries, Inc.
Effective date
2017-11-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:09:42

Label at a glance#

ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure11 sections

Indications and uses

for relief of occasional constipation (irregularity). This product generally produces a bowel movement within 12 to 72 hours.

Dosage and administration

Adults and children 12 years of age and older : Take 1 tablet as needed, not to exceed more than 3 tablets daily, or as directed by a doctor. Children under 12 years of age : Consult a doctor before use.

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool Softener

Uses

INDICATIONS & USAGE SECTION

  • for relief of occasional constipation (irregularity). This product generally produces a bowel movement within 12 to 72 hours.

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • laxative products for longer than one week unless directed to do so by a doctor
  • if you are presently taking mineral oil unless told to do so by a doctor

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a doctor before use.

Keep out of Reach of Children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: Take 1 tablet as needed, not to exceed more than 3 tablets daily, or as directed by a doctor.

Children under 12 years of age: Consult a doctor before use.

Other information

SPL UNCLASSIFIED SECTION

  • Each tablet contains: Calcium 40 mg
  • Each tablet contains: Sodium 10 mg
  • Store at room temperature
  • Do not use if imprinted safety seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized Starch, Silica, Sodium Benzoate, Stearic Acid.

Questions?

OTC - QUESTIONS SECTION

If you have any questions or comments, or to report an adverse event, please contact 1-800-MEDLINE.

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Purdue Products, L.P., owner of the registered trademark Colace®

SPL UNCLASSIFIED SECTION

Distributed By: Medline Industries, INc.

One Medline Place, Mundelein,IL

60060 USA www.medline.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53329-660-30

*Compare to the Active Ingredient in Colace ®

DOCUSATE SODIUM

STOOL SOFTENER

Relieves Occasional Constipation (Irregularity)

100 mg

100 Tablets - 100 mg each

LabelLabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130884389823333GTIN-13: 0884389823333
EAN-13: 0884389823333
GTIN-12: 884389823333
UPC-A: 884389823333
GTIN storage (14 digits): 00884389823333		100ct.jpg

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-66053329-660-30

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
NameUNIIKind
MAGNESIUM STEARATE70097M6I30IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
HYPROMELLOSES3NXW29V3WOIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM BENZOATEOJ245FE5EUIACT
STEARIC ACID4ELV7Z65APIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB

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
995b21a2-ae38-a8af-e053-2a95a90a151c2bfdfbbd-dc5c-3dc0-e054-00144ff88e882019-12-10WarningsExact identifier
spl set id: 2bfdfbbd-dc5c-3dc0-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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