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

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

Age	Starting Dosage	Maximum Dosage
adults & children 12 years of age & over	2 tablets once a day	4 tablets twice a day
children 6 to under 12 years of age	1 tablet once a day	2 tablets twice a day
children 2 to under 6 years	½ tablet once a day	1 tablet twice a day
children under 2 years	ask a doctor	ask 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

INGREDIENTS AND APPEARANCE

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 68210-4180-5	50 in 1 POUCH; Type 0: Not a Combination Product	11/22/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	11/22/2021

Labeler - Spirit Pharmaceuticals LLC (179621011)

Stool Softener and Laxative by