FDA.reportPublic FDA data

Stool Softener DC Laxative

Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2013-04-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:47:03

Label at a glance#

ProductStool Softener DC Laxative
Active ingredientDOCUSATE CALCIUM
Label structure8 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: Atlantic Biologicals Corp

Miami, Fl 33179

image descriptionimage description

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-3700-12020-01-31C16284748780-19d75b9d0-cf73-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-3700-1Stool Softener DC Laxative1 in 1 POUCHCAPSULE, LIQUID FILLED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-3700STOOL SOFTENER DC LAXATIVE (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [ATLANTIC BIOLOGICALS CORP.]1Legacy NDC, 1 package rows20160909_0174e485-a3b3-4e42-9619-2c063d122417.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 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17856-370017856-3700-1
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

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
32e3b0cb-965a-40f0-b0ce-931b61805e750174e485-a3b3-4e42-9619-2c063d1224172013-04-24WarningsExact identifier
spl id: 32e3b0cb-965a-40f0-b0ce-931b61805e75
spl set id: 0174e485-a3b3-4e42-9619-2c063d122417

Reported adverse events (FAERS/openFDA)#

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