STOOL SOFTENER- docusate sodium capsule, liquid filled 
Allegiant Health

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424-Stool Softener- Single Tone

Active ingredient(s)

Docusate sodium 100mg

Purpose

Stool softener

Use(s)

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

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

Stop use and ask a doctor if

  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
  • you need a laxative for more than 1 week

Pregnancy/Breastfeeding

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.

Adults and children 12 years and over: take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.

Children 2 to under 12 years of age: take 1 softgel daily

Children under 2 years of age: ask a doctor

Other information

Storage

Store at room temperature 15°-30°C (59°-86°F), protect from excessive humidity.

Inactive ingredients

Anhydrous citric acid, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol,

propylene glycol, purified water, sorbitol sorbitan solution and white edible ink.

Questions

Call 1-888-952-0050 Monday to Friday 9am-5pm

Principal Display Panel

Stool Softener

Stool Softener


STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-424
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
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 SOLUTION (UNII: 8KW3E207O2)  
Product Characteristics
ColorredScoreno score
ShapeCAPSULESize13mm
FlavorImprint Code PC1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-424-81400 in 1 BOTTLE; Type 0: Not a Combination Product04/20/2021
2NDC:69168-424-32100 in 1 BOTTLE; Type 0: Not a Combination Product05/20/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00701/28/2015
Labeler - Allegiant Health (079501930)

Revised: 4/2021
Document Id: c35dda2c-6127-4f02-9ae2-330b7a22a973
Set id: 9fbe783e-ddd9-445a-852a-00f4ad754880
Version: 6
Effective Time: 20210420
 
Allegiant Health