Docusate Calcium 240 mg sodium free

Manufacturer
National Vitamin Company
Effective date
2020-04-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:35:06

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

  • Keep lid tightly closed.
  • 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 (800) 682-9862

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54629-0640-01

LIFE-LINE®

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

LIFE-LINE VITAMINS
U.S.A.
Since 1974

Manufactured and Distributed by
NATIONAL VITAMIN COMPANY
Casa Grande, AZ 85122

LabelLabel

Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54629-640-012020-04-18C16284748780-19d75b9cf-ea5c-f424-e053-dadaa90a57ceDocusate Calcium 240 mg Sodium Free
54629-640-012020-01-31C16284748780-19d75b9cf-ea5c-f424-e053-dadaa90a57ceDocusate Calcium 240 mg Sodium Free

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
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
54629-64054629-640-01

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 · 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
87a422b1-85da-4779-98df-b45e77d5dfb752139708-8a21-4fc5-b375-c6f9064cce222025-01-06WarningsExact identifier
spl set id: 52139708-8a21-4fc5-b375-c6f9064cce22

Reported adverse events (FAERS/openFDA)#

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