DOCUSATE SODIUM- docusate sodium 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 Sodium, USP
Stool Softener

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool Softener

Keep Out of Reach of Children.

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

Uses

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 or you fail to have a bowel movement after use.

If you are pregnant or breast-feeding,

ask a healthcare professional before use.

Directions

Adults and Children over 12 years of age Take orally 1 to 2 softgels preferably at bedtime for
2-3 days or until bowel movements are normal, or as directed by a doctor.
Children 6 to 12 years of age Take orally 1 softgel preferably at bedtime for
2-3 days or until bowel movements are normal, or as directed by a doctor.
Children under 6 years of age Do not use this product for children under 6 years of age, unless directed by a doctor.

Other Information

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Ink (Edible), Polyethylene Glycol, Propylene Glycol, Purified Water, Sorbitol

Questions

Call 1 (800) 682-9862

Package/Label Principal Display Panel

NDC 54629-600-01
Life-Line®
Docusate Sodium, USP
Stool Softener
100 mg Each
100 Softgels

Manufactured and Distributed by
National Vitamin Company
Casa Grande, AZ 85122

Bottle Label

Bottle Label

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54629-600
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 100 mg
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color RED Score no score
Shape OVAL Size 12mm
Flavor Imprint Code NV13
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54629-600-01 100 in 1 BOTTLE
2 NDC:54629-600-99 1000 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 05/01/2000
Labeler - National Vitamin Company (102098324)
Establishment
Name Address ID/FEI Business Operations
National Vitamin Company 102098324 MANUFACTURE(54629-600)
Establishment
Name Address ID/FEI Business Operations
Swiss Caps USA, Inc 033105888 MANUFACTURE(54629-600)

Revised: 6/2012
Document Id: 800fb383-3bb3-424a-a729-d9cd57a37a1e
Set id: 800fb383-3bb3-424a-a729-d9cd57a37a1e
Version: 1
Effective Time: 20120626
 
National Vitamin Company