STOOL SOFTENER REGULAR STRENGTH- docusate sodium capsule, liquid filled 
Spirit Pharmaceuticals LLC

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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Stool Softener Regular Strength

Drug Facts

Active Ingredient (in each tablet)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

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

• fever • mucus in the stool

Ask a doctor or pharmacist before use if you are if you have

• stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that lasts 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 stool softener 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 right away. (1-800-222-1222)

Directions

take only by mouth. Doses may be taken as asingle daily dose or in divided doses.

adults & children 12 years of age & overtake 1–3 softgels daily
children 2 to under 12 years of agetake 1 softgel daily
children under 2 years of ageask a doctor

Other information

• store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F) • Keep tightly closed

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, purified water, sorbitol solution

Questions or comments?

1-888-333-9792

Distributed by:

Cabinet Health P.B.C.

Pouch

Stool Softener

STOOL SOFTENER REGULAR STRENGTH 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4176
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)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize12mm
FlavorImprint Code 125
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-4176-330 in 1 POUCH; Type 0: Not a Combination Product11/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33411/22/2021
Labeler - Spirit Pharmaceuticals LLC (179621011)
Registrant - Spirit Pharmaceuticals LLC (179621011)
Establishment
NameAddressID/FEIBusiness Operations
MEDGEL PRIVATE LIMITED677385498manufacture(68210-4176)

Revised: 11/2021
 
Spirit Pharmaceuticals LLC