SENNA-S- sennosides and docusate sodium tablet, film coated 
Kinray Inc.

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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Drug Facts

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

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


age starting dosage maximum 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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:61715-019
Route of Administration ORAL DEA Schedule     
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)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color orange (orange) Score no score
Shape ROUND (round shape) Size 10mm
Flavor Imprint Code S90
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61715-019-60 1 in 1 CARTON
1 60 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 05/10/2011
Labeler - Kinray Inc. (012574513)
Registrant - Pharbest Pharmaceuticals Inc. (557054835)
Establishment
Name Address ID/FEI Business Operations
Pharbest Pharmaceutical Inc. 557054835 repack(61715-019) , relabel(61715-019)

Revised: 3/2013
Document Id: cf166ebb-d7d8-4a5e-921b-514d8576ca07
Set id: 92b25368-f009-45f0-929f-c1831ff02c04
Version: 1
Effective Time: 20130326
 
Kinray Inc.