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Senna S

TOP CARE (Topco Associates LLC)
P and L Development of New York Corporation

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Laxative

Senna S Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6-12 hours

Warnings

Do not use

  • if you are now taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week 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 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
 age starting dosage  maximum dosage 
adults and children 12 years of age or older 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 

Senna S Other information

  • each tablet contains: calcium 20 mg
  • each tablet contains: sodium 6 mg VERY LOW SODIUM
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

carnauba wax*, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake*, FD&C red #40 aluminum lake*, FD&C yellow #6 aluminum lake, hypromellose*, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, purified water*, silicon dioxide, sodium benzoate*, stearic acid, talc*,  titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call toll free: 1-888-423-0139

Principal Display Panel

STIMULANT LAXATIVE

Senna-S

DOCUSATE SODIUM, 50 mg • SENNOSIDES, 8.6 mg

•Natural Vegetable Laxative Ingredient

Plus Stool Softener

TABLETS

COMPARE TO SENOKOT-S® active ingredients**   

**This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot-S®.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL  60007

topcare@topco.com

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Labeling

Senna S
Top Care Senna-S Tablet

Senna S

DOCUSATE SODIUM, SENNOSIDES TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:36800-162
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 50 mg
SENNOSIDES SENNOSIDES 8.6 mg

Inactive Ingredients

Ingredient Name Strength
carnauba wax
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C YELLOW NO. 6
HYPROMELLOSES
MAGNESIUM STEARATE
maltodextrin
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
water
SILICON DIOXIDE
SODIUM BENZOATE
STEARIC ACID
talc
titanium dioxide
ALUMINUM OXIDE

Product Characteristics

Color Size Imprint Code Shape
ORANGE 10 mm TCL081;SS1;S35 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 BOTTLE, PLASTIC
2 NDC:36800-162-60 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2013-03-15


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Be sure to consult your doctor before taking any medication!
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