STOOL SOFTENER MAXIMUM STRENGTH- docusate sodium capsule, liquid filled 
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

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

Uses

  • for the prevention of dry, hard stools
  • for relief of occasional constipation
  • this product generally produces a bowel movement within 12 to 72 hours

Warnings

Do not use

  • if you are currently taking mineral oil, unless directed by a doctor
  • when abdominal pain, nausea, or vomiting are present
  • for more than 1 week, unless directed by a doctor

Ask a doctor before use if

you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use

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

  • adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
  • children under 12 years of age: take as directed by a doctor

Other information

  • each softgel contains: sodium 15 mg
  • store at controlled room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

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

Principal Display Panel

Maximum Strength

Stool Softener

Docusate Sodium, 250 mg

  • Relieves constipation

Softgels

Visit us at: Rexall.com or call 1-866-4-REXALL

PACKAGED FOR DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN  37072  USA

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Package Label

Docusate Sodium 250 mg

Rexall Maximum Strength Stool Softener Softgel

 

STOOL SOFTENER  MAXIMUM STRENGTH
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-150
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 (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code P20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-150-101 in 1 BOX04/30/201301/01/2020
1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33404/30/201301/01/2020
Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)
Registrant - P & L Development, LLC (800014821)

Revised: 12/2018
Document Id: 22e42d5b-6f7a-448a-b550-c5e8f00e0df6
Set id: fb650726-b307-46df-9d68-efe5dc027a34
Version: 2
Effective Time: 20181203
 
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)