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

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

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

  • take only by mouth. Doses may be taken as a single daily dose or in divided doses.
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

  • each softgel contains:sodium 7 mg
  • store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)
  • Keep tightly closed.


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:53345-008)
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: 181a370b-91a2-cf28-e063-6394a90a389a
Set id: 5d300ea7-78eb-4e19-8333-1e42c73c4c54
Version: 7
Effective Time: 20240510
 
PD-Rx Pharmaceuticals, Inc.