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

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 or you fail to have a bowel movement after use.

If you are 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 right away.

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

Each softgel contains 5 mg of Sodium.
Keep lid tightly closed.
Store at room temperature between 15°C to 30°C (59°F to 86°F).
Do not use if printed seal under cap is broken or missing.
For identification purposes, each softgel will have an imprint that reads NV13.

Inactive ingredients

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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:54629-600
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorREDScoreno score
ShapeOVALSize12mm
FlavorImprint Code NV13
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54629-600-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2000
2NDC:54629-600-991000 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2000
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/01/2000
Labeler - National Vitamin Company (102098324)
Establishment
NameAddressID/FEIBusiness Operations
National Vitamin Company102098324MANUFACTURE(54629-600)
Establishment
NameAddressID/FEIBusiness Operations
SWISSCAPS Romania srl565466997MANUFACTURE(54629-600)

Revised: 4/2020
Document Id: 6786b7c4-5d1c-458a-ae03-819d4726dbba
Set id: 800fb383-3bb3-424a-a729-d9cd57a37a1e
Version: 3
Effective Time: 20200410
 
National Vitamin Company