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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DOK Plus Tablets

Active Ingredients (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Purpose
Stool Softener
Stimulant Laxative

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

Warnings

Ask a doctor before use if you have

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.

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

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. 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

pdp

SENNA/DOCUSATE SODIUM 
docusate sodium and sennosides tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45865-913(NDC:0904-5643)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorredScoreno score
ShapeROUNDSize10mm
FlavorImprint Code TCL097
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45865-913-3030 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/01/2010
Labeler - medsource pharmaceuticals (833685915)
Establishment
NameAddressID/FEIBusiness Operations
medsource pharmaceuticals833685915repack(45865-913)

Revised: 12/2018
Document Id: 7df0e98a-07c6-94d8-e053-2a91aa0ab227
Set id: 7df0e98a-07c5-94d8-e053-2a91aa0ab227
Version: 1
Effective Time: 20181226
 
medsource pharmaceuticals