SENNA/DOCUSATE SODIUM- docusate sodium and sennosides tablet, film coated

Senna/Docusate Sodium by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

PURPOSE

Purpose
Stool Softener
Stimulant Laxative

INDICATIONS & USAGE

Uses relieves occasional constipation (irregularity). This product generally produces a bowel movement in 6 to 12 hours.

WARNINGS

Warnings

Ask a doctor before use if you have

• Stomach pain
• Nausea
• Vomiting
• A sudden change in bowel habits that lasts over a period of 2 weeks.

DO NOT USE

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

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

Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are presently taking mineral oil.

DOSAGE & ADMINISTRATION

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

• Age:

  Dosage

• Adults and children 12 years of age and older:

  Take 2-4 tablets daily

• Children 6 to under 12 years:

  Take 1-2 tablets daily

• Children 2 to 6 years:

  Take up to 1 tablet daily

• Children under 2 years:

  Do not use

Generic Section

Other information

• Each tablet contains: sodium 6 mg/tablet VERY LOW SODIUM
• Each tablet contains: calcium 20 mg/tablet.
• Store at 20° - 25°C (68° -77°F); excursions permitted to 15°-30° (59°-86°F). [See USP Controlled Room Temperature]

INACTIVE INGREDIENT

Inactive Ingredients: Carnauba Wax, Colloidal Silicon Dioxide, Croscarmellose Sodium, Dibasic Calcium Phosphate Dihydrate, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, tapioca starch*, tartaric acie*, and titanium dioxide. *may contain these ingredients.

KEEP OUT OF REACH OF CHILDREN

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

Questions

Questions? To Report Serious Adverse Effects Call: (800)616-2471

Distributed By:

Major® Pharmaceuticals

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152 USA

LHC51790417

PRINCIPAL DISPLAY PANEL

DOK Plus Tablets

(Docusate Sodium & Sennosides)

50/8.6 mg

100 Tablets

INGREDIENTS AND APPEARANCE

SENNA/DOCUSATE SODIUM 
docusate sodium and sennosides tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-5643(NDC:49483-097)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL097
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-5643-61	100 in 1 BOX, UNIT-DOSE	01/01/2010	03/31/2022
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0904-5643-60	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2010	05/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/01/2010	05/31/2022

Labeler - Major Pharmaceuticals (191427277)

Registrant - Major Pharmaceuticals (191427277)