DOCUSATE SODIUM- docusate sodium capsule, liquid filled 
Contract Pharmacy Services-PA

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 100 mg

DRUG FACTS

ACTIVE INGREDIENT (IN EACH CAPSULE)

Docusate sodium 100 mg

PURPOSE

Stool softener

USES

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 movements that continues over a period of 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 signs of a serious condition.
  • you need to use a stool softener laxative for more than 1 week

If pregnant or breast-feeding,

ask a health 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

FD&C Red No. 40, FD&C Yellow No. 6, edible ink, gelatin, glycerin, polyethylene blycol, propylene glycol, purified water and sorbitol special

QUESTIONS OR COMMENTS?

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

call toll free 734-743-6000

Repackaged by:

Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA

Original--07/2010--NJW

Package Label

100 mg

Blister of 60 Capsules

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-139(NDC:0904-7889)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Product Characteristics
ColorRED (Transparent red) Scoreno score
ShapeCAPSULE (oblong softgel) Size10mm
FlavorImprint Code P51
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67046-139-3030 in 1 BLISTER PACK
2NDC:67046-139-6060 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/30/2010
Labeler - Contract Pharmacy Services-PA (945429777)

Revised: 7/2010
Document Id: 808abf28-a936-4d62-bb94-9fbe51c571c4
Set id: 808abf28-a936-4d62-bb94-9fbe51c571c4
Version: 1
Effective Time: 20100730
 
Contract Pharmacy Services-PA