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PlusPHARMA by Gemini Pharmaceuticals, Inc. dba Plus Pharma

Dosage form: tablet, chewable
Ingredients: SIMETHICONE 80mg
Labeler: Gemini Pharmaceuticals, Inc. dba Plus Pharma
NDC Code: 51645-860

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
  • Adults: Chew 1 or 2 tablets as needed after meals and at bedtime.
  • Do not exceed 6 tablets per day except under the advice and supervision of a physician.

Other Information
  • Store at room temperature.
  • Avoid high humidity.
  • Do not use if imprinted safety seal under cap is broken or missing.

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 (800) 795-9775.


Principal Display Panel

PlusPHARMA

SIMETHICONE 80 mg

ANTI GAS

Acts Fast to Relieve:



  • Bloating
  • Discomfort
  • Pressure

Compare to the Active Ingredient in Gas-X® Chewables.

This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Gas-X® Chewables.

100 CHEWABLE TABLETS 80mg Each

PLUSPHARMA  
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51645-860
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
FRUCTOSE 
MALTODEXTRIN 
SILICON DIOXIDE 
SORBITOL 
STARCH, CORN 
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeROUND (Round Flat Faced Beveled Edge) Size13mm
FlavorSPEARMINT (Natural and Artificial) Imprint CodeGPI;LB
Contains    
Packaging
#Item CodePackage Description
1NDC:51645-860-01100 TABLET, CHEWABLE (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/27/2006
Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
Registrant - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
Establishment
NameAddressID/FEIOperations
Gemini Pharmaceuticals, Inc. dba Plus Pharma055942270manufacture(51645-860)

Revised: 03/2006
 
Gemini Pharmaceuticals, Inc. dba Plus Pharma

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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