STOOL SOFTENER  EXTRA STRENGTH- docusate sodium capsule, liquid filled 
Atlantic Biologicals Corps

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

Warnings - Do not use

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

Other information

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?

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STOOL SOFTENER EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED

Label Image
STOOL SOFTENER   EXTRA STRENGTH
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0443(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:17856-0443-11 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33407/09/2010
Labeler - Atlantic Biologicals Corps (047437707)
Registrant - Atlantic Biologicals Corps (047437707)
Establishment
NameAddressID/FEIBusiness Operations
Atlantic Biologicals Corps047437707RELABEL(17856-0443) , REPACK(17856-0443)

Revised: 11/2012
Document Id: 66f70512-0231-48f7-b4ee-296aa63bd397
Set id: eaf13cb4-46e1-4cee-9b0f-90706d74fbd0
Version: 2
Effective Time: 20121109
 
Atlantic Biologicals Corps