FDA.reportPublic FDA data

DOK

Manufacturer
Cardinal Health 107, LLC
Effective date
2022-11-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:46:32

Label at a glance#

ProductDOK
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

• take with a glass of water • take only by mouth. Doses may be taken as a single daily dose or in divided doses. adults and children 12 years and over take 1 to 3 capsules daily children 2 to under 12 years of age take 1 capsule daily children under 2 years of age ask a doctor

Storage and handling

• each capsule contains: sodium 6 mg Very Low Sodium • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) • protect from excessive humidity • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN • see end flap for expiration date and lot number 

Label contents#

Full prescribing information#

Active ingredient (in each liquid-filled capsule)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100 mg 

Purpose

OTC - PURPOSE SECTION

Stool softener laxative 

Very low Sodium

Each capsules contains: sodium 6 mg

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • 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
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

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 (1-800-222-1222) right away. 

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take with a glass of water
  • take only by mouth. Doses may be taken as a single daily dose or in divided doses.

adults and children 12 years and over

take 1 to 3 capsules daily

children 2 to under 12 years of age

take 1 capsule daily

children under 2 years of age

ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each capsule contains: sodium 6 mg Very Low Sodium
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from excessive humidity
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • see end flap for expiration date and lot number 

Questions or comments?

OTC - QUESTIONS SECTION

(800) 616-2471 

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, propylene glycol, purified water, sorbitol

Distributed by MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA

Product of China

Packaged and Quality Assured in the USA

MFGD By PuraCap Pharm., LLC NJ 07080

Distributed by:

Cardinal Health

Dublin, OH 43017

L51685130421

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DOK 100 mg

Docusate Sodium

10 Softgels

bag label
bag label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6455-61EA - Each0904-645531d7e7f0-bb8b-4da4-a281-75987bced57812015-11-12

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55154-763655154-7636-0
0904-6455

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
MINERAL OILT5L8T28FGPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT

Source Document#

Source XML · Source PDF

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
33f88bef-e8d3-4faf-9956-762aa872d008a656ab2b-a644-4fbb-9717-c0cf19ed31782022-11-22WarningsExact identifier
spl id: 33f88bef-e8d3-4faf-9956-762aa872d008
spl set id: a656ab2b-a644-4fbb-9717-c0cf19ed3178

Reported adverse events (FAERS/openFDA)#

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