STOOL SOFTENER- docusate sodium capsule, liquid filled 
Bryant Ranch Prepack

----------

Drug Facts

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

  • 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 signs of a serious condition.
  • you need to use a 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

Other information

Inactive Ingredients

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol, propylene glycol, purified water, sorbitan sorbitol


Questions or comments?

Call 1-800-616-2471

HOW SUPPLIED

Docusate Sodium 250 mg

NDC: 71335-9738-1: 30 Capsules in a BOTTLE

NDC: 71335-9738-2: 60 Capsules in a BOTTLE

NDC: 71335-9738-3: 100 Capsules in a BOTTLE

NDC: 71335-9738-4: 7 Capsules in a BOTTLE

NDC: 71335-9738-5: 90 Capsules in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

Docusate Sodium 250 mg Capsule

Label
STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-9738(NDC:0904-6999)
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
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
MANNITOL (UNII: 3OWL53L36A)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColororangeScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code P20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-9738-130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/26/2023
2NDC:71335-9738-260 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/21/2023
3NDC:71335-9738-3100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/30/2024
4NDC:71335-9738-47 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/20/2023
5NDC:71335-9738-590 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00709/30/2019
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-9738) , RELABEL(71335-9738)

Revised: 5/2024
Document Id: 8ef804c3-f8e8-4922-b48a-b2967413c699
Set id: dde828ea-839d-41c7-a4bd-ec9671e48f77
Version: 101
Effective Time: 20240530
 
Bryant Ranch Prepack