STOOL SOFTENER- docusate sodium 100 mg capsule 
Allegiant Health

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

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

  • relieves occasional constipation (irregularity) 
  • generally produces bowel movement in 12 to 72 hours

Warnings

Do Not Use

  • if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you

  • stomach pain 
  • nausea 
  • vomiting
  • noticed a sudden change in bowel habits that lasts over a period of 2 weeks

Stop use and ask a doctor if you

 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 stool softener laxative for more than 1 week      

If pregnant or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep Out of Reach of Children

In case of accidental overdose, get medical help or contact a Poison Control Center(1-800-222-1222) right away.

Directions

  • Take only by mouth. Doses may be taken as a single daily dose or in divided doses. 
  • Adults and children 12 years and over take 1-3 softgels daily.
  • Children 2 to under 12 years of age take 1 softgel daily.
  • Children under 2 years ask a doctor. 

Other Information

  • each softgel contains: sodium 5mg

  • VERY LOW SODIUM
  • store at 25°C (77°F) excursions permitted between 15°– 30°C (59°–86°F) 

Inactive Ingredients

  • Black edible ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special.

Package/Label Principal Display Panel

Docusate Sodium

Docusate Sodium


STOOL SOFTENER 
docusate sodium 100 mg capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-314
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)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SORBITOL (UNII: 506T60A25R)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-314-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/23/201409/30/2023
2NDC:69168-314-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/23/201409/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33412/23/201409/30/2023
Labeler - Allegiant Health (079501930)

Revised: 12/2018
Document Id: fa6046a7-752e-4972-9aba-6db2318916c6
Set id: 418d81eb-933b-4457-ac20-603cc985d0f2
Version: 6
Effective Time: 20181226
 
Allegiant Health