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PlusPHARMA by Proficient Rx LP

Dosage form: tablet, chewable
Ingredients: SIMETHICONE 80mg
Labeler: Proficient Rx LP
NDC Code: 63187-516

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

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

PLUSPHARMA 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-516(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:63187-516-00100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/27/2006
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079196022REPACK(63187-516), RELABEL(63187-516)

 
Proficient Rx LP

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Medically reviewed on Feb 1, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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