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

----------

Drug Facts
Docusate Sodium

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

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 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 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 (1-800-222-1222)  right away.

Directions

adults and children 12 years and overtake 1 to 3 softgels daily.
children 2 to under 12 years of agetake 1 softgel daily
children under 2 years ask a doctor

Other information

Inactive ingredients

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

Questions or comments?

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

HOW SUPPLIED

For identification purposes, each orange softgel will have an imprint that reads P51.

NDC 72789-295-30 Bottles of 30 softgels.

NDC 72789-295-90 Bottles of 90 softgels.

Principal Display Panel

Docusate Sodium

Stool Softener Laxative

TAMPER EVIDENT: DO NOT USE IF SEAL IS BROKEN OR MISSING FROM BOTTLR.

Product Label

72789295 Label
DOCUSATE SODIUM 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72789-295(NDC:50804-862)
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
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
SORBITAN (UNII: 6O92ICV9RU)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize12mm
FlavorImprint Code P51
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72789-295-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/23/2022
2NDC:72789-295-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/23/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00705/28/2021
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIBusiness Operations
PD-Rx Pharmaceuticals, Inc.156893695repack(72789-295)

Revised: 10/2023
Document Id: 06c1eaf8-cbe7-2af7-e063-6294a90a863e
Set id: 2d657c29-c701-4db0-9c06-f680bd921241
Version: 5
Effective Time: 20231002
 
PD-Rx Pharmaceuticals, Inc.