SENNA- sennosides a and b 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.

----------

Senna Tablets

Active Ingredient

Sennosides 8.6 mg

Purpose

Laxative

Uses:

Relieves occasional constipation (irregularity)

Generally causes a bowel movement in 6 - 12 hours

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, or noticed a sudden change in bowel movements that continues over a period of 2 weeks

Stop use ans ask a doctor if you have rectal bleeding or 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.

Adults and children over 12 years of age: Starting dosage 2 tablets once a day.  Maximum Dosage 4 tablets twice a day.

Children 6 to under 12 years of age:  Starting dosage 1 tablets once a day.  Maximum Dosage 2 tablets twice a day.

Children 2 to under 6 years of age: Starting dosage 1/2 tablet once a day.  Maximum Dosage 1 tablet twice a day.

Children under 2 years of age: Ask a doctor

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, *dicalcium phosphate anhydrous, hypermellose, maltodextrin, magnesium stearate, microcrystalline cellulose, *mineral oil, *polyethylene glycol (PEG), stearic acid, talc, triacetin. 

*May also contain.

Package Labeling

Compare to the active ingredient in Senokot

Senna Laxative
Natural Vegetable Laxative

Standardized Senna Concentrate

100 Senna Tablets
Sennosides 8.6mg each

label
SENNA 
sennosides tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51824-198
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES A AND B (SENNOSIDES A AND B) SENNOSIDES A AND B8.6 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
HYPROMELLOSES 
MALTODEXTRIN 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
TALC 
TRIACETIN 
Product Characteristics
ColorBROWN (Light brown speckled with dark brown) Scoreno score
ShapeROUND (Round) Size9mm
FlavorImprint Code S3;S8;TCL080
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-198-01100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33411/11/201004/28/2015
Labeler - New World Imports (075372276)

Revised: 5/2012
Document Id: 6a617c11-4c53-459f-ad31-bad2c73c1828
Set id: e4877c84-4609-4022-b3af-39eca8fa8f19
Version: 6
Effective Time: 20120515
 
New World Imports