GENTLE STOOL SOFTENER- docusate sodium capsule 
Chain Drug Consortium, LLC

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 100 mg

Purpose

Stool softener

Uses

  • temporary relief of occasional constipation.
  • this product generally produces a bowel movement within 12 to 72 hours.

Warnings - Do not use

  • if abdominal pain, nausea or vomiting are present

Ask a doctor before use if

  • you notice a sudden change in bowel habits that persists over a period of 2 weeks
  • you are presently taking mineral oil

Stop use and ask a doctor if

  • rectal bleeding or failure to have a bowel movement occur after use which may indicate a serious condition 
  • you need to use a laxative for more than 1 week

If pregnant or breastfeeding

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 right away.

Directions

 adults and children 12 years of age and over take 1 to 3 softgels daily
 children 2 to under 12 years of age take 1 softgel daily
 children under 2 years of age ask a doctor

Other information

  • each softgel contains: sodium 6 mg
  • store at controlled room temperature 15o - 30o C (59o- 86o F)
  • do not use if imprinted safety seal under cap is broken or missing.
  • *This product is not manufactured or distributed by Boehringer Ingelheim Consumer Healthcare, owner of the registered trademark of Dulcolax®

Inactive Ingredients

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

Questions or comments?

call toll free 1-877-753-3935

Principal Display Panel

*Compare to the active ingredient in Dulcolax® Stool Softener

GENTLE STOOL SOFTENER

DOCUSATE SODIUM, 100 mg per Softgel

For fast, dependable relief of occasional constipation

DISTRIBUTED BY:

CHAIN DRUG CONSORTIUM, LLC.

BOCA RATON, FL 33431

Product Label

 Premier Value stool softener 25 count

Docusate sodium 100 mg

GENTLE STOOL SOFTENER 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-192
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize13mm
FlavorImprint Code P51
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-192-251 in 1 BOX07/08/201012/01/2017
125 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 finalpart33407/08/201012/01/2017
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - P & L Development, LLC (079765031)

Revised: 12/2021
Document Id: 574d2e5f-ad2a-40eb-9d49-00007c005b9a
Set id: a0d9850a-8b86-470f-90df-3bce3eae742a
Version: 4
Effective Time: 20211216
 
Chain Drug Consortium, LLC