DOCUSATE CALCIUM 240 MG SODIUM FREE- docusate calcium capsule, liquid filled 
National Vitamin Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Docusate Calcium 240 mg Sodium Free

Active ingredient

Docusate Calcium 240 mg

Purpose

Stool Softener

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.

Warnings: 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 one week unless directed by a doctor.

Ask a Doctor Before Use

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

Stop Use and Ask a Doctor If

You have rectal bleeding.
You fail to have a bowel movement after use.

If Pregnant or Breast Feeding

Ask a healthcare professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

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

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

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

Questions or Comments

Call 1 (800) 682-9862

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

Label

Label

DOCUSATE CALCIUM 240 MG SODIUM FREE 
docusate calcium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54629-640
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG) DOCUSATE CALCIUM240 mg
Inactive Ingredients
Ingredient NameStrength
CORN OIL (UNII: 8470G57WFM)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorREDScoreno score
ShapeOVALSize15mm
FlavorImprint Code NV02
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54629-640-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/01/2016
Labeler - National Vitamin Company (102098324)
Registrant - National Vitamin Company (102098324)
Establishment
NameAddressID/FEIBusiness Operations
National Vitamin Company102098324MANUFACTURE(54629-640) , ANALYSIS(54629-640)

Revised: 6/2016
Document Id: 52139708-8a21-4fc5-b375-c6f9064cce22
Set id: 52139708-8a21-4fc5-b375-c6f9064cce22
Version: 1
Effective Time: 20160629
 
National Vitamin Company