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 250 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 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 softgel preferably at bedtime for
2-3 days or until bowel 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

Each softgel contains 13 mg of Sodium.
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 NV12.

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 54629-601-01
Life-Line®
Docusate Sodium, USP
Stool Softener
250 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:54629-601
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM250 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
ShapeOVALSize20mm
FlavorImprint Code NV12
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54629-601-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2000
2NDC:54629-601-991000 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(54629-601)

Revised: 4/2020
Document Id: 8194c8a5-d1e9-428d-ab41-a782ffde2b70
Set id: 0c66642c-82cb-42cd-82bb-5f95852cc5d1
Version: 2
Effective Time: 20200410
 
National Vitamin Company