Docusate Calcium 240 mg sodium free

Manufacturer
AvPAK
Effective date
2023-10-31
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 21:22:48

Label at a glance#

ProductDocusate Calcium 240 mg sodium free
Active ingredientDOCUSATE CALCIUM
Label structure13 sections

Indications and uses

For the relief of occasional constipation. Helps to prevent dry, hard stools. This product generally produces a bowel movement within 12 to 72 hours.

Dosage and administration

Adults and Children over 12 years of age Take orally 1 softgel daily for 2 to 3 days or until bowl movements are normal, or as directed by a doctor. Children under 12 years of age Do not use this product for children under 12 years of age, unless directed by a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Docusate Calcium 240 mg

Purpose

OTC - PURPOSE SECTION

Stool Softener

Uses

INDICATIONS & USAGE SECTION

  • For the relief of occasional constipation.
  • Helps to prevent dry, hard stools.
  • This product generally produces a bowel movement within 12 to 72 hours.

Warnings: Do not use

WARNINGS SECTION

  • If you are currently taking mineral oil, unless directed by a doctor.
  • When abdominal pain, nausea or vomiting are present.
  • For longer than one week unless directed by a doctor.

Ask a Doctor Before Use

OTC - ASK DOCTOR SECTION

if you notice a sudden change in bowel habits that persists over a period of two 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.

If Pregnant or Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a healthcare 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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and Children over 12 years of age

Take orally 1 softgel daily for 2 to 3 days or until bowl movements are normal, or as directed by a doctor.

Children under 12 years of age

Do not use this product for children under 12 years of age, unless directed by a doctor.

Other Information

OTHER SAFETY INFORMATION

  • Store at room temperature between 15ºC to 25ºC (59ºF to 77ºF).
  • Do not use if either seal is broken or missing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Corn Oil, FD&C Blue #1, FD&C Red #40, Gelatin, Glycerin, Ink (Edible), Sorbitol Special.

Questions or Comments

OTC - QUESTIONS SECTION

Call 1-855-361-3993                 

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50268-266-15

AvKARE                    

DOCUSATE
CALCIUM
SODIUM-FREE
STOOL SOFTENER
240 mg Each
100 Softgels

USA
AV Rev. 05/16 (P)          

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

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DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-266-11EA - Each50268-2665709f1a6-e123-4803-bf8b-e3071675094212017-06-15
50268-266-15EA - Each50268-26604d34c8a-2385-4ff6-b222-748b08f9d08012017-06-15
54629-640-01EA - Each54629-640e7b360d4-49b7-4263-b874-f0bfa7c4555a12016-07-19

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
50268-26650268-266-11, 50268-266-15
54629-640

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
28eed024-f3bf-b00e-e063-6294a90aafc530ea2e6f-62f4-462e-ad70-5ec77cb82ae52024-12-10WarningsExact identifier
spl set id: 30ea2e6f-62f4-462e-ad70-5ec77cb82ae5

Reported adverse events (FAERS/openFDA)#

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