DOCUSATE SENNOSIDES tablet, film coated

DOCUSATE SENNOSIDES by

Drug Labeling and Warnings

DOCUSATE SENNOSIDES by is a Otc medication manufactured, distributed, or labeled by DIRECTRX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Each Tablet contains:

Docustate sodium 50 mg

Sennosides 8.6 mg

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, d-c yellow#10 aluminum lake fd&c yelow#6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

PURPOSE

stool softner, laxative

DOSAGE & ADMINISTRATION

Directions:

Take preferably at bedtime or as directed by a doctor. If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (not to exceed maximum dosage) or decrease dose until you are comfortable.

Adults and children 12 years and over - starting dosage: 2 tablets once a day maximum dosage: 4 tablets twice a day

Children 6 to under 12 years - starting dosage: 1 tablet once a day maximum dosage: 2 tablets twice a day

Children to2 to under 6 years - starting dosage: 1/2 tablet once a day maximum dosage: 1 tablet twice a day

Children under 2 years - Ask a doctor

INDICATIONS & USAGE

Uses:

Relieves occasional constipation (irregularity); generally causes bowel movement in 6-12 hours

WARNINGS

WARNINGS:

Do not use this product

If you are presently taking mineral oil, unless directed by a doctor

Laxative products for longer than 1 week unless directed by a doctor

KEEP OUT OF REACH OF CHILDREN

keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOCUSATE SENNOSIDES 
docusate sennosides tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61919-771(NDC:49483-081)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN)	SENNOSIDES A AND B	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL081
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-771-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	04/29/2019

Labeler - DIRECTRX (079254320)

Registrant - DIRECTRX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DIRECTRX		079254320	repack(61919-771)