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

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.

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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 lasts 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, polyethylene glycol, propylene glycol*, purified water, sorbitol special

*may contain this ingredient

Questions or comments?

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

HOW SUPPLIED

Product: 71335-0632

NDC: 71335-0632-1 30 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0632-2 60 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0632-3 100 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0632-4 7 CAPSULE, LIQUID FILLED in a BOTTLE

Docusate Sodium 250mg Capsule

Label Image
STOOL SOFTENER  EXTRA STRENGTH
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0632(NDC:0536-1064)
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)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code P20;SCU1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-0632-130 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
2NDC:71335-0632-47 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
3NDC:71335-0632-260 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
4NDC:71335-0632-3100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33401/31/2015
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-0632) , RELABEL(71335-0632)

Revised: 1/2020
Document Id: 7ff5b843-e930-4718-804b-c6e0d555b29d
Set id: ed53b4fb-c1aa-4738-b2dd-8a2f9c75e39b
Version: 3
Effective Time: 20200119
 
Bryant Ranch Prepack