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DOCUSATE SODIUM by NCS HealthCare of KY, Inc dba Vangard Labs

Medically reviewed on November 16, 2017

Dosage form: capsule
Ingredients: DOCUSATE SODIUM 100mg
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
NDC Code: 0615-7901

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.

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Warnings

Do not use

if you are presently taking mineral oil, unless told to do so by a doctor.

Ask a doctor before use if you have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be a signs of a serious condition.
  • you need to use a laxative for more than 1 week

If pregnant or breast-feeding,

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
  • take only by mouth. Doses may be taken as a single daily dose or in divided doses.
 adults and children 12 years of age and over take 1 to 3 softgels daily.
 children 2 to under 12 years of age take 1 softgel daily
 children under 2 years of age ask a doctor

Other information
  • each softgel contains: sodium 7 mg
  • store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, medium-chain triglycerides*, polyethylene glycol, propylene glycol*, purified water sorbitan, sorbitol

*contains one or more of these ingredients

Questions or comments?

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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**Compare to the active ingredient in Colace®

DOK™ 100mg

Docusate sodium

Stool Softener

For Use as a Stool Softener in Treating & Avoiding Constipation

Softgels

**This product is not manufactured or distributed bt Purdue Products L.P., owner of the registerd trademark Colace®

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by:

MAJOR® PHARMACEUTIALS

31778 Enterprise Drive

Livonia, MI 48150, USA

M-58              Rev 01/15

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Principal Display Panel

 

DOCUSATE SODIUM 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-7901(NDC:0904-6457)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
SORBITAN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
GLYCERIN 
MEDIUM-CHAIN TRIGLYCERIDES 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize12mm
FlavorImprint CodeP51
Contains    
Packaging
#Item CodePackage Description
1NDC:0615-7901-306 BLISTER PACK in 1 BOX, UNIT-DOSE
15 CAPSULE in 1 BLISTER PACK
2NDC:0615-7901-3930 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33402/28/2015
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIOperations
NCS HealthCare of KY, Inc dba Vangard Labs050052943RELABEL(0615-7901), REPACK(0615-7901)

 
NCS HealthCare of KY, Inc dba Vangard Labs

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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