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

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DRUG FACTS

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

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks


Stop use and ask a doctor if

  • you have rectal bleeding or fail to have a bowel movement after using a laxative. These could be a sign 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 care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-2222-1222) right away.

Directions

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

Other information


Inactive ingredients

citric acid, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitol special, white edible ink


Questions or comments?

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

Principal Display Panel

DOCUSATE SODIUM, 100 mg

STOOL SOFTENER LAXATIVE

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

72789399 Label
DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72789-399(NDC:0904-7280)
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)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorredScoreno score
ShapeCAPSULE (Oval) Size13mm
FlavorImprint Code PC1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72789-399-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/10/2024
2NDC:72789-399-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/10/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00711/15/2022
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIBusiness Operations
PD-Rx Pharmaceuticals, Inc.156893695repack(72789-399)

Revised: 5/2024
Document Id: 19215ffc-e2fa-0e08-e063-6394a90a6716
Set id: 5d300ea7-78eb-4e19-8333-1e42c73c4c54
Version: 8
Effective Time: 20240523
 
PD-Rx Pharmaceuticals, Inc.