STOOL SOFTENER AND LAXATIVE- docusate sodium and sennosides tablet, film coated 
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 and Laxative

Drug Facts

Active Ingredient (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Laxative

Uses

• relieves occasional constipation (irregularity) • generally produces bowel movement in 6–12 hours

Warnings

• relieves occasional constipation (irregularity) • generally produces bowel movement in 6–12 hours

Do not use

• if you are now taking mineral oil, unless directed by a doctor • laxative products for longer than 1 week, unless directed by a doctor

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use

if you are if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

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 preferably at bedtime or as directed by a doctor

AgeStarting DosageMaximum Dosage
adults & children 12 years of age & over2 tablets once a day4 tablets twice a day
children 6 to under 12 years of age1 tablet once a day2 tablets twice a day
children 2 to under 6 years½ tablet once a day1 tablet twice a day
children under 2 yearsask a doctorask a doctor

Other information

• each tablet contains: calcium 20 mg and sodium 6 mg
• store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F)

Inactive ingredients

Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Yellow No. 10, FD&C Yellow No. 6, hypromellose, magnesium stearate, microcrystalline cellulose, maltodextrin, polyethylene glycol 400, purified water, sodium benzoate, stearic acid, titanium dioxide

Questions or comments?

1-888-333-9792

Distributed by:

Cabinet Health P.B.C.

Pouch

Stool Softener and Laxative

STOOL SOFTENER AND LAXATIVE 
docusate sodium and sennosides tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4180
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize10mm
FlavorImprint Code S44
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-4180-550 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
Elysium Pharmaceuticals Ltd915664486manufacture(68210-4180)

Revised: 11/2021
 
Spirit Pharmaceuticals LLC