Your browser does not support JavaScript! DOCUSATE SODIUM AND SENNA (DOCUSATE SODIUM AND SENNA ) TABLET, FILM COATED [RUGBY LABORATORIES, INC]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

DOCUSATE SODIUM AND SENNA (docusate sodium and senna ) tablet, film coated
[Rugby Laboratories, Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredients (in each tablet)
Docusate Sodium 50 mg
Sennosides 8.6 mg

Purposes
Stool Softener
Stimulant Laxative

Uses
  • relieves occasional constipation
  • generally produces bowel movement in 6-12 hours

Warnings

Do not use
  • for longer than one week
  • if you are taking mineral oil
  • when abdominal pain, nausea or vomiting are present

Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if
  • you have rectal bleeding
  • you fail to have a bowel movement after use of this product.
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
adults and children 12 years and over: 2-4 tablets once daily or in divided doses
children 6 to under 12 years: 1-2 tablets once daily or in divided doses
children 2 to under 6 years: 1/2-1 tablet once daily or in divided doses
children under 2 years: ask a doctor

Other information
  • each tablet contains: calcium 20 mg, sodium 6 mg (LOW SODIUM)
  • store at 20°-25°C (68°-77°F)

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD-C blue #2 aluminum lake, FD-C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG), sodium benzoate, stearic acid, titanium dioxide

Questions or comments?
call 1-800-645-2158, 9 am - 5 pm ET, Monday - Friday


BOTTLE LABEL

DOCUSATE SODIUM AND SENNA  
docusate sodium and senna tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0536-0355
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg
SENNOSIDES (SENNOSIDES) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
FD&C BLUE NO. 2 
FD&C RED NO. 40 
HYPROMELLOSE 2910 (6 MPA.S) 
HYPROMELLOSE 2910 (15 MPA.S) 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
SODIUM BENZOATE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
Colorpurple (burgundy) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code TCL;131
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-0355-01100 in 1 BOX
2NDC:0536-0355-101000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/22/2011
Labeler - Rugby Laboratories, Inc (109178264)
Registrant - Time Cap Labs, Inc (037052099)
Establishment
NameAddressID/FEIBusiness Operations
Time Cap Labs, Inc037052099manufacture

Revised: 9/2011
 
Rugby Laboratories, Inc

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services