BLONIL - simethicone tablet, chewable 
Amvilab LLC

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.

----------

Drug Facts

Active ingredient (in each tablet)

Simethicone 80 mg, USP


Purpose

Anti-Gas


Uses

Relieves bloating and pressure commonly referred to as gas.


Warnings


If pregnant or breast-feeding, ask a health professional before use.


Keep this and all drugs out of the reach of children.


Directions

Other Information

Inactive ingredients

Fructose, Maltodextrin, Natural and Artificial Spearmint Flavor, Silicon Dioxide, Sorbitol, Starch and Stearic Acid.


Questions?

If you have any questions or comments, or to report an adverse event, please contact +1 404 256 8817.


Principal Display Panel

BLONIL

Simethicone 80 mg

Anti Gas

Relieves Gas Fast

100 CHEWABLE TABLETS 80mg Each

untitled.jpg
BLONIL 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69975-870
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
FRUCTOSE (UNII: 6YSS42VSEV)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SORBITOL (UNII: 506T60A25R)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUND (Round Flat Faced Beveled Edge) Size13mm
FlavorSPEARMINT (Natural and Artificial) Imprint Code GPI;LB
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69975-870-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/16/2015
Labeler - Amvilab LLC (006092439)
Registrant - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
Establishment
NameAddressID/FEIBusiness Operations
Gemini Pharmaceuticals, Inc. dba Plus Pharma055942270manufacture(69975-870)

Revised: 7/2015
Document Id: 998ce6dd-0c91-407a-8d3d-992f3f688165
Set id: 352c3aa1-0935-4fc7-b154-4ee1107c7357
Version: 1
Effective Time: 20150716
 
Amvilab LLC