STOOL SOFTENER- docusate sodium 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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420-Stool Softener

Active ingredient(s)

Docusate sodium 100mg

Purpose

Stool softener

Use(s)

 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 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

Directions


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

Other information

 each capsule contains: sodium 5mg
 VERY LOW SODIUM

Storage

 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

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 not finalpart33404/10/2015
Labeler - Allegiant Health (079501930)

Revised: 10/2020
 
Allegiant Health