DOK PLUS tablet, film coated

DOK Plus by

Drug Labeling and Warnings

DOK Plus by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each tablet)	Purposes
Docusate sodium 50 mg	Stool softener
Sennosides 8.6 mg	Stimulant laxative

Each tablet contains: calcium 20 mg, sodium 6 mg (VERY LOW SODIUM)

PURPOSE

	Purposes
Docusate sodium 50 mg	Stool softener
Sennosides 8.6 mg	Stimulant laxative

Uses

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

WarningsWARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only.

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 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

Ask a doctor or pharmacist before use

• if you are presently taking mineral oil

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement after use of a laxative.
• you need to use a laxative for more than 1 week
• you have no bowel movement or have rectal bleeding. 

These could be signs of a serious condition

If pregnant or breast-feeding, ask a health professional before use.

Keep this and all drugs out of the reach of children. In case of overodse, 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.

age	dosage
adults and children 12 years and older	take 2-4 tablets daily
children 6 to under 12 years	take 1-2 tablets daily
children 2 to under 6 years	take up to 1 tablet daily
children under 2 years	Ask a doctor

Other information

• each tablet contains: sodium 6 mg/tablet VERY LOW SODIUM
• each tablet contains:  calcium 20 mg/tablet

Store at 25ºC (77ºF); excursions permitted to 15º - 30ºC (59°- 86°F).  [See USP Controlled Room -Temperature]

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 and titanium dioxide. 

Questions?

To Report Serious Adverse Drug Event: (800) 616-2471

SPL UNCLASSIFIED SECTION

Distributed by:

MAJOR® PHARMACEUTICALS

17177 N. Laurel Park Dr., Suite 233 Livonia, MI 48152  USA       

Distributed by:

Cardinal Health

Dublin, OH 43017

L37710941018

PRINCIPAL DISPLAY PANEL

DOK PLUS TABLETS 50/8.6 mg.

Docusate Sodium & Sennosides

10 Tablets

INGREDIENTS AND APPEARANCE

DOK PLUS 
dok plus tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55154-0733(NDC:0904-5643)
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
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: 55154-0733-0	10 in 1 BAG	06/07/2011
1		1 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	06/07/2011

Labeler - Cardinal Health (603638201)