SENNA LAXATIVE- sennosides tablet 
New World Imports

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

Warnings

Do Not Use

  • 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 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 dosagemaximum dosage 
 adults and children over 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


Other information


Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, liquid paraffin*, magnesium stearate, maltodextrin*, microcrystalline cellulose, mineral oil*, silicon dioxide*, stearic acid*, sodium lauryl sulfate*, talc*, triacetin*

*contains one or more of these ingredients

Principal Display Panel

Compare to the active ingredient in SENOKOT®†

Senna Laxative 

Natural Vegetable Laxative

Standardized Senna Concentrate

Senna Tablets  8.6 mg each

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

Distributed by:

NWI, Inc., 160 Athens Way

Nashville, TN 37228

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

Product Label

Sennosides 8.6 mg

NWI Senna Laxative Tablets

SENNA LAXATIVE 
sennosides tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51824-037
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (SENNOSIDES) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
SILICON DIOXIDE 
STEARIC ACID 
SODIUM LAURYL SULFATE 
TALC 
TRIACETIN 
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize9mm
FlavorImprint Code S3;TCL080;S8
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-037-01100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33410/30/2013
Labeler - New World Imports (075372276)

Revised: 11/2013
Document Id: 8ef5387b-daad-4ff9-a89e-6a09d040c69f
Set id: 1950b26b-2348-4b7e-9831-54686bc36220
Version: 1
Effective Time: 20131108
 
New World Imports