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Senna

Western Family Foods, Inc.

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Senna Uses

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement within 6- 12 hours.

WarningsDo not use

  • laxative products for longer than 1 week unless directed by a doctor.

Ask a doctor before using if

you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel movements that continues over a period of 2 weeks.

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use. These may indicate a serious condition.

If pregnant or breast-feeding,

ask a health care 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 over 12 years of age  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 Other information


  • each tablet contains: calcium 25 mg/ tablet
  • store at 25o C (77o F); excursions permitted between 15o - 30o C (59o- 86o F)
  • do not use if imprinted safety seal under cap is broken or missing.

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, *dicalcium phosphate anhydrous, hypromellose,  maltodextrin*, magnesium stearate, microcrystalline cellulose, *mineral oil, *polyethylene glycol, stearic acid, talc, and triacetin

*May also contain.

Principal Display Panel

Compare to active ingredient in senokot® *

Senna

Natural vegetable laxative

Sennosides 8.6 mg

Proudly distributed by Western Family Foods Inc.,

PO Box 4057, Portland, OR 97208

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

Questions or comments? Call toll free 1-877-753-3935

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Labeling

Senna
Sennosides 8.6 mg

Senna

SENNOSIDES TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55312-180
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SENNOSIDES SENNOSIDES 8.6 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
HYPROMELLOSES
MAGNESIUM STEARATE
maltodextrin
cellulose, microcrystalline
Mineral Oil
POLYETHYLENE GLYCOLS
SILICON DIOXIDE
STEARIC ACID
talc
triacetin

Product Characteristics

Color Size Imprint Code Shape
BROWN 9 mm S3;TCL080;S8 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE
2 NDC:55312-180-01 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2010-07-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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