SENNOSIDES, DOCUSATE SODIUM tablet, film coated

Sennosides, Docusate sodium by

Drug Labeling and Warnings

Sennosides, Docusate sodium by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

PURPOSE

Purposes

Stool softener

Stimulant laxative

Uses 

• for overnight relief from occasional constipation (irregularity)
• generally produces bowel movement in 6 to 12 hours

WARNINGS

Do not use 

• laxative products for longer than 1 week unless directed by a doctor 
• if you are now taking mineral oil, 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 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 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 may indicate a serious condition.

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.

Directions

• take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.

• adults and children 12 years and older:

  take 2-4 tablets daily

• children 6 to under 12 years of age:

  take 1-2 tablets daily

• children 2 to under 6 years of age:

  take up to 1 tablet daily

• children under 2:

  ask a doctor

Other information

• each tablet contains: calcium 11 mg
• each tablet contains: sodium 4 mg
• store at 25°C (77°F); excursions permitted between 15º-30ºC (59º-86ºF)

INACTIVE INGREDIENT

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide and triacetin.

Questions or comments?

Call 1 (800) 616-2471

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by: MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152 USA

†This product is not manufactured or distributed by Purdue Products L.P., distributor of Colace®2-IN-1.

PRINCIPAL DISPLAY PANEL

MAJOR ®

NDC: 0904-6723-60

A Stimulant Laxative & Stool Softener For Use in the Management of Temporary Constipation

DOK TM PLUS

(Docusate Sodium 50 mg and Sennosides 8.6 mg)

Compare to the active ingredients in COLACE®2-IN-1†

100 Tablets

INGREDIENTS AND APPEARANCE

SENNOSIDES, DOCUSATE SODIUM 
sennosides, docusate sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6723
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 (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
TALC (UNII: 7SEV7J4R1U)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	CPC;490
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6723-60	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2019	12/31/2021
2	NDC: 0904-6723-61	10 in 1 BOX	03/07/2019	04/30/2022
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/31/2019	04/30/2022

Labeler - Major Pharmaceuticals (191427277)