SENNA NATURAL VEGETABLE LAXATIVE- sennosides tablet 
Western Family Foods, 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 Ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

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

Warnings
Do 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


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

Western Family Senna Laxative

Sennosides 8.6 mg

SENNA  NATURAL VEGETABLE LAXATIVE
sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-180
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize9mm
FlavorImprint Code S3;TCL080;S8
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-180-011 in 1 BOX07/01/201012/31/2019
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33407/01/201012/31/2019
Labeler - Western Family Foods, Inc. (192166072)

Revised: 12/2018
Document Id: 2cf3c3a8-1683-4916-9196-44c07fb6d26d
Set id: ef028ea8-5a4a-4128-86e5-6ff97f5b599c
Version: 3
Effective Time: 20181228
 
Western Family Foods, Inc.