PLUSPHARMA- simethicone tablet, chewable 
Proficient Rx LP

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)

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

63187-516-00
PLUSPHARMA 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-516(NDC:51645-860)
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:63187-516-00100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/27/2006
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(63187-516) , RELABEL(63187-516)

Revised: 1/2021
Document Id: cf994666-c728-4a3b-a73e-f3709cbb141b
Set id: 4242fb32-a04f-4f46-99e2-ca01fcb2ee9f
Version: 3
Effective Time: 20210101
 
Proficient Rx LP