DOCUSATE SODIUM- docusate sodium capsule 
PD-Rx Pharmaceuticals, Inc.

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

Uses

Warnings


Do not use

Do not use if you are currently taking mineral oil, unless directed bya doctor

Ask a doctor before use if you

  • stomach pain, nausea or vomiting
  • have noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if

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

you need to use a stool softner 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

adults and children over 12 years and older                        
take 1-3 softgels daily
children 2 to 12 years of age
take 1 softgel daily
children under 2 years
ask a doctor

Other information

Inactive ingredients: FD&C Red #33,Edible Ink,FD&C Red #40,FD&C Yellow #6, Gelatin, Glycerin, Polyethylene Glycol, Purified Water, Sorbitol Special.


Questions?

Adverse drug event call: (866) 562-2756

HOW SUPPLIED

Supplied in bottles of 14, 30, 60, 90 and 180 softgels.

Principal Display Panel

*Compare to the active ingredient of Colace®

Docusate Sodium

Stool Softener

100 mg each

image

DOCUSATE SODIUM 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55289-493
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Colorred (Two-toned- white and clear red) Scoreno score
ShapeOVALSize12mm
FlavorImprint Code SC02
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55289-493-1414 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2018
2NDC:55289-493-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2018
3NDC:55289-493-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2018
4NDC:55289-493-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2018
5NDC:55289-493-93180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/12/201801/31/2038
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIBusiness Operations
PD-Rx Pharmaceuticals, Inc.156893695repack(55289-493)

Revised: 12/2019
Document Id: 98ceb596-d141-2be7-e053-2995a90a2d67
Set id: 66ca7a94-378b-4476-8060-d9c6f82f57fc
Version: 8
Effective Time: 20191203
 
PD-Rx Pharmaceuticals, Inc.