STOOL SOFTENER EXTRA STRENGTH- docusate sodium capsule, liquid filled 
AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385

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 over 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 - 30o C (59o- 86o F)
  • do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

edible white ink, FD&C Red No# 40, FD&C Yellow No# 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

Questions or comments?

Call toll free 1-877-753-3935

Product Label

Extra strength

Stool Softener

Docusate sodium 250 mg

Relieves constipation

Good Neighbour Pharmacy stool softener softgels

Docusate sodium 250 mg

 

STOOL SOFTENER  EXTRA STRENGTH
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-443
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 GLYCOLS (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:24385-443-78100 in 1 BOTTLE; Type 0: Not a Combination Product07/09/201012/12/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33407/09/201012/12/2018
Labeler - AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 (007914906)

Revised: 10/2016
Document Id: 52b9a885-edb8-48d4-b130-2b4906a70d12
Set id: 96ab8a0a-b70a-4689-acad-f90b8499029e
Version: 2
Effective Time: 20161024
 
AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385