Docusate Calcium

Manufacturer
Rebel Distributors Corp
Effective date
2011-09-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:27

Label at a glance#

ProductDocusate Calcium
Active ingredientDOCUSATE CALCIUM
Label structure10 sections

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 at controlled room temperature 15 degrees-30 degrees C (59 degrees-86 degrees F)

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Docusate Calcium

Purpose

OTC - PURPOSE SECTION

Stool Softener

Use(s)

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

-Do not use 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.

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST 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

Pregnancy/Breastfeeding

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

SPL UNCLASSIFIED SECTION

-do not use if imprinted safety seal under cap is broken or missing

-This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Surfak Stool Softener

Storage

STORAGE AND HANDLING SECTION

Store at controlled room temperature 15 degrees-30 degrees C (59 degrees-86 degrees F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Corn oil, D&C Red #33, FD&C Red #40, gelatin, glycerin, purified water and sorbitol special.

Questions

OTC - QUESTIONS SECTION

Adverse Drug Event Call: (800) 616-2471

Distributed by: Rugby Laboratories, Inc. Duluth GA 30097

Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Docusate Calcium Softgel Capsules

240mg

Docusate Calcium 240mg
Docusate Calcium 240mg

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
21695-980-072019-09-24C16284748780-1934fe258-4b6c-48b1-e053-8cdaa90a720aDocusate Calcium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-980-07Docusate Calcium07 in 1 BOTTLECAPSULE071

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-980DOCUSATE CALCIUM CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20111227_f5480c36-4401-49f2-b550-912e01527ac8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-980-07EA - Each21695-9805259c913-3587-423c-89a2-e7b544ad149812012-07-24
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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DOCUSATE CALCIUMACTIVE INGREDIENT6K7YS503HC1
DOCUSATEACTIVE MOIETYM7P27195AG1

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
21695-98021695-980-07
0536-3755

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
f5480c36-4401-49f2-b550-912e01527ac8f5480c36-4401-49f2-b550-912e01527ac82011-09-07WarningsExact identifier
spl id: f5480c36-4401-49f2-b550-912e01527ac8
spl set id: f5480c36-4401-49f2-b550-912e01527ac8

Reported adverse events (FAERS/openFDA)#

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