DOCUSATE SODIUM, EXTRA STRENGTH 250 MG- docusate sodium capsule, gelatin coated 
Advanced Rx LLC

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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Advanced Rx - PUREGEN - DOCUSATE SODIUM 250MG (80513-101)

ACTIVE INGREDIENT (IN EACH SOFTGEL)

DOCUSATE SODIUM 250 MG

PURPOSE

Stool softener laxative

USES

WARNINGS

Do not use if you are presently taking mineral oil, unless directed by a doctor.


Ask a doctor before use if you have

Stop use and ask a doctor if

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 (1-800-222-1222) right away.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

FD&C red #40, FD&C yellow #6, gelatin, glycerin, ink (edible), polyethylene glycol, propylene glycol, purified water, sorbitol.

QUESTIONS?

call 1-800-630-8895

PDP

DF

DOCUSATE SODIUM, EXTRA STRENGTH  250 MG
docusate sodium capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80513-101
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
GELATIN TYPE B BOVINE (160 BLOOM) (UNII: 1T8387508X)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize21mm
FlavorImprint Code NV12
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80513-101-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/25/2023
Labeler - Advanced Rx LLC (042795108)

Revised: 5/2023
Document Id: fc8cf24e-8ca2-b3fb-e053-6294a90a7a50
Set id: fc8cf24e-8ca1-b3fb-e053-6294a90a7a50
Version: 1
Effective Time: 20230525
 
Advanced Rx LLC