FDA.reportPublic FDA data

Docusate calcium

Manufacturer
Central Texas Community Health Centers | P and L Development of New York Corporation
Effective date
2016-03-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:40

Label at a glance#

ProductDocusate calcium
Active ingredientDocusate calcium
Label structure9 sections

Indications and uses

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

Dosage and administration

adults and children over 12 years of age: take 1 softgel daily for several days, or until bowel movements are normal, or as directed by a doctor children under 12 years of age : take as directed by a doctor

Storage and handling

store between 15º-30ºC (59º-86ºF)

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate Calcium 240 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • if  you are currently taking mineral oil, unless directed by a doctor
  • when abdominal pain, nausea, or vomiting are present
  • for longer than 1 week, unless directed by a doctor

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding
  • you fail to have a bowel movement after use

These could be signs of s serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care 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

  • adults and children over 12 years of age: take 1 softgel daily for several days, or until bowel movements are normal, or as directed by a doctor
  • children under 12 years of age: take as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • store between 15º-30ºC (59º-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn oil, D&C red #33, edible white ink, FD&C red #40, gelatin, glycerin, purified water and sorbitol special.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to active ingredient in SURFAK®*

Safe, Effective, Non-Habit Forming

Stool Softener Laxative DC

Docusate Calcium USP, 240 mg

SOFTGEL CAPSULES

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

*Rugby Laboratories is not affiliated with the owner of the trademark Surfak®.

Distributed by: Rugby Laboratories

31778 Enterprise Drive

Livonia, MI  48150

www.rugbylaboratories.com

PRINCIPAL DISPLAY PANEL - 240 mg Capsule Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CommUnityCare Federally Qualified Health Centers

DOCUSATE
CALCIUM
240 MG
CAPS

Date:

Name:
Dr.

TAKE 1 CAPSULE BY MOUTH DAILY AS DIRECTED.

123456

1/1/01

DOCUSATE CA.240MG CAPS#30NDC 76413-307-30

Batch: 123456
Lot: 123456
Exp: 1/1/01
MAJOR

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

PRINCIPAL DISPLAY PANEL - 240 mg Capsule Bottle Label
PRINCIPAL DISPLAY PANEL - 240 mg Capsule Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245376docusate calcium 240 MG Oral CapsulePSN1
1245376docusate calcium 240 MG Oral CapsuleSCD1
1245376DOSS Calcium 240 MG Oral CapsuleSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76413-307-302020-01-31C16284748780-19d75b9d0-a4a4-f424-e053-dadaa90a57ceDocusate calcium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-307-30Docusate calcium30 in 1 BOTTLECAPSULE, LIQUID FILLED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-307DOCUSATE CALCIUM CAPSULE, LIQUID FILLED [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]1Legacy NDC, 1 package rows20160408_fbb8e974-5360-4ad4-bfcf-23063a586693.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-3755-01EA - Each0536-3755ecbcc8af-b3d3-49e5-b321-e3b36584fdd712012-07-24
0536-3755-05EA - Each0536-3755b8d3bfa9-e542-4c89-ace2-885d60aa9fa012012-07-24
0536-3755-10EA - Each0536-375593023aa5-4144-402c-a303-c47b5483447d12012-07-24

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76413-30776413-307-30
0536-3755

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
NameUNIIKind
Docusate calcium6K7YS503HCACTIB
CORN OIL8470G57WFMIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
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
e8e8dd30-2442-40c6-a6f8-6768acc84b7bfbb8e974-5360-4ad4-bfcf-23063a5866932016-03-22WarningsExact identifier
spl id: e8e8dd30-2442-40c6-a6f8-6768acc84b7b
spl set id: fbb8e974-5360-4ad4-bfcf-23063a586693

Reported adverse events (FAERS/openFDA)#

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