DOCUSATE SODIUM- docusate sodium capsule, liquid filled 
NCS HealthCare of KY, Inc dba Vangard Labs

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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Drug Facts

Active Ingredient (in each softgel)

Docusate Sodium 100mg

Purpose

Stool softener

Uses

This product generally produces a bowel movement within 12 to 72 hours.

Warnings - Do not use

Ask a doctor before use if

you notice a sudden change in bowel habits that persists over a period of 2 weeks

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use

If pregnant or breastfeeding

ask a health care 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

Other information

Inactive Ingredients

edible ink, FDandC Red #40, FDandC Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

Questions or comments?

Adverse Drug Event Call: (800)-616-2471)

Distributed by : Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, U.S.A.

Rev. 2/09

Principal Display Panel

Principal Display Panel-Docusate Sodium 100mg Docusate Sodium Capsule 100mg unit dose label

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0615-0585(NDC:0904-7889)
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 GLYCOLS (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color ORANGE (ORANGE) Score no score
Shape OVAL (OVAL) Size 13mm
Flavor Imprint Code P51
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0615-0585-30 6 in 1 BOX, UNIT-DOSE
1 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2 NDC:0615-0585-05 15 in 1 BLISTER PACK; Type 0: Not a Combination Product
3 NDC:0615-0585-31 31 in 1 BLISTER PACK; Type 0: Not a Combination Product
4 NDC:0615-0585-39 30 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part334 04/23/2010
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
Name Address ID/FEI Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs 050052943 REPACK(0615-0585)

Revised: 1/2015
Document Id: 058f0cf7-469c-4aa0-a95f-4f53de559d45
Set id: 7cdecfb2-e09a-4b48-b9d6-00045518825e
Version: 7
Effective Time: 20150106
 
NCS HealthCare of KY, Inc dba Vangard Labs