STOOL SOFTENER by Chain Drug Consortium, LLC Drug Facts

STOOL SOFTENER by

Drug Labeling and Warnings

STOOL SOFTENER by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STOOL SOFTENER EXTRA STRENGTH- docusate sodium capsule, liquid filled 
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 250 mg

Purpose

Stool softener laxative

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 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

  • 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: ask a doctor

Other information

  • each softgel contains: sodium 15 mg
  • store at 20º-25ºC (68º-77ºF); excursions permitted between 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

*may contain this ingredient

Questions or comments?

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

Principal Display Panel

Extra Strength Stool Softener

STIMULANT-FREE

RELIEF OF CONSTIPATION

Docusate sodium 250 mg

Softgels

DISTRIBUTED BY: CHAIN DRUG CONSORTIUM, LLC.

3301 NW BOCA RATON BLVD.

SUITE 101

BOCA RATON, FL 33431

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

Package Label

Docusate sodium 250 mg

Premier Value Extra Strength Stool Softener Softgel

STOOL SOFTENER  EXTRA STRENGTH
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68016-532
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)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code P20;SCU1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68016-532-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/201401/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33404/30/201401/31/2020
Labeler - Chain Drug Consortium, LLC (101668460)

Revised: 12/2018
Document Id: c96ea93a-846e-4666-8be7-83b51e047be5
Set id: d6b7f0f7-acaf-45bf-ad5c-1be1742f6325
Version: 3
Effective Time: 20181206