STOOL SOFTENER LAXATIVE- docusate sodium capsule, liquid filled 
ATLANTIC BIOLOGICALS CORP.

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Drug Facts

Active ingredient (in each softgel)

 Docusate sodium 250 mg

Purpose

 Stool softener laxative

Uses

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 last 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 (1-800-222-1222) right away.

Directions

Other information

Inactive Ingredients

anhydrous citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mannitol, mineral oil, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, white ink 

Questions?

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

Principal Display Panel

Extra Strength

Docusate Sodium

250 mg

Stool Softener Laxative

Softgels

Distributed by:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Product Label

label

STOOL SOFTENER LAXATIVE 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-7281(NDC:0904-7281)
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)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MANNITOL (UNII: 3OWL53L36A)  
MINERAL OIL (UNII: T5L8T28FGP)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
Colororange (Clear) Scoreno score
ShapeCAPSULESize20mm
FlavorImprint Code P4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-7281-1100 in 1 BOX, UNIT-DOSE02/20/2024
1NDC:17856-7281-21 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM10/14/2022
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
UNIT DOSE SOLUTIONS360804194repack(17856-7281)

Revised: 2/2024
Document Id: 07bf7617-0cfe-4a99-b901-f4772e212e17
Set id: c1f588d0-4600-4b97-b2d3-2c08ac351e07
Version: 1
Effective Time: 20240220
 
ATLANTIC BIOLOGICALS CORP.