Your browser does not support JavaScript! SENNA-S (SENNOSIDES AND DOCUSATE SODIUM) TABLET, FILM COATED [KINRAY INC.]
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RxNorm Names

SENNA-S (sennosides and docusate sodium) tablet, film coated
[Kinray 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

Sennosides from Senna Concentrate 8.6 mg

Sodium Dioctylsulfosuccinate 50 mg

Purposes

Sennosides from Senna Concentrate 8.6 mg...........Laxative
Sodium Dioctylsulfosuccinate 50 mg......................Stool Softener

Uses

  • Relieves occasional constipation (irregularity)
  • Generally produces a bowel movement in 6-12 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 continues 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.

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 preferably at bedtime or as directed by a doctor

agestarting dosagemaximum dosage
adults and children 12 years of age and over
2 tablets once a day
4 tablets twice a day
children 6 to under 12 years
1 tablet once a day
2 tablets twice a day
children 2 to under 6 years
1/2 tablet once a day
1 tablet twice a day
children under 2 years
ask a doctor
ask a doctor

Other Information

  • each tablet contains calcium 20 mg, sodium 6mg Low Sodium
  • store at room temperature between 15-300C (59-860F)

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, tapoica starch, tartaric acid, titanium dioxide

Questions? Adverse drug event call: (866) 562-2756

PP Senna-S 60ct carton
SENNA-S 
sennosides and docusate sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61715-019
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (SENNOSIDES) SENNOSIDES8.6 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
SODIUM BENZOATE 
STEARIC ACID 
STARCH, TAPIOCA 
TARTARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
Colororange (orange) Scoreno score
ShapeROUND (round shape) Size10mm
FlavorImprint Code S90
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-019-601 in 1 CARTON
160 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/10/2011
Labeler - Kinray Inc. (012574513)
Registrant - Pharbest Pharmaceuticals Inc. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceutical Inc.557054835repack(61715-019), relabel(61715-019)

Revised: 3/2013
 
Kinray Inc.

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