STOOL SOFTENER- docusate sodium capsule 
Allegiant Health

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420-Stool Softener

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

you have

  • 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 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

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

Adults and children 12 years and over: take 1-3 softgels, daily. Doses 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: ask a doctor

Other information

Storage

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

Questions

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

Principal Display Panel

Stool Softener

Stool Softener


STOOL SOFTENER 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-420
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)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorred, whiteScoreno score
ShapeCAPSULESize13mm
FlavorImprint Code PC18
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-420-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/10/2015
2NDC:69168-420-81400 in 1 BOTTLE; Type 0: Not a Combination Product04/30/2021
3NDC:69168-420-3030 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00704/10/2015
Labeler - Allegiant Health (079501930)

Revised: 10/2020
Document Id: 6eb62390-6dc1-4038-a518-5a8b94cc51dc
Set id: 30c9ff75-cee4-4632-86fd-acfdf5ee85af
Version: 8
Effective Time: 20201027
 
Allegiant Health