STOOL SOFTENER- docusate sodium capsule, liquid filled 
Shopko Stores Operating Co., LLC.

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Drug Facts

Active Ingredient (in each softgel)

Docusate Sodium 100mg

Purpose

Stool softener

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 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 stool softener laxative for more than 1 week

If pregnant or breastfeeding

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

  • Take only by mouth. Doses may be taken as a single daily dose or in divided doses.
 adults and children over 12 years and over take 1- 3 softgels daily
 children 2 to under 12 years of age take 1 softgel daily
 children under 2 years ask a doctor

Other information

  • each softgel contains: sodium 6 mg
  • store at controlled room temperature 15o - 30o C (59o- 86o F)
  • *This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®

Inactive Ingredients

D&C Red #33, edible ink, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, and titanium dioxide

Questions or comments?

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

Principal display panel

*compare to colace® active ingredient

STOOL SOFTENER

Relieves occasional constipation

Docusate Sodium, 100 mg

safe, gentle & reliable

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

PACKAGED BY: PL Developments

200 hicks street

westbury NY 11590

Product Labeling

Shopko Stool softener 100 mg

Docusate sodium 100 mg

 

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-110
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
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)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorred (WHITE) Scoreno score
ShapeOVALSize13mm
FlavorImprint Code P10;51A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37012-110-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/09/201012/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00707/09/201012/01/2017
Labeler - Shopko Stores Operating Co., LLC. (023252638)

Revised: 5/2024
Document Id: 4f182ae8-2d1e-48d2-85ad-3f7fb5ce7b35
Set id: 9031c063-b21f-45e0-be9e-897510957594
Version: 2
Effective Time: 20240522
 
Shopko Stores Operating Co., LLC.