PLUS PHARMA- simethicone tablet, chewable
Gemini Pharmaceuticals, Inc. dba Plus Pharma

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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Simethicone 125 mg

Active ingredient (in each chewable tablet)

Simethicone 125 mg, USP

Purpose

Antigas

Uses

Relieves bloating and pressure commonly referred to as gas.

Warnings

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

Keep out of the reach of children.

Directions

Adults: Chew 1 or 2 tablets as needed after meals and at bedtime
Do not take more than 4 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

NDC 51645-0870-06

SIMETHICONE 125 mg

EXTRA STRENGTH

ANTI-GAS

Acts Fast to Relieve:

Bloating
Discomfort
Pressure

*Compare to active ingredient in Gas-X® Extra Strength.

*Plus Pharma is not affiliated with the owner of the registered trademark Gas-X®.

60 CHEWABLE TABLETS 125mg Each

PLUS PHARMA
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51645-870
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Ingredient Name	Strength
Inactive Ingredients
FRUCTOSE (UNII: 6YSS42VSEV)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (uncoated)	Score	2 pieces
Shape	ROUND (Round Flat Faced Beveled Edge)	Size	16mm
Flavor	SPEARMINT (Natural and Artificial)	Imprint Code	G23
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51645-870-06	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/03/2014	06/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	11/03/2014	06/30/2020

Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)

Name	Address	ID/FEI	Business Operations
Establishment
Gemini Pharmaceuticals, Inc. dba Plus Pharma		055942270	manufacture(51645-870)

Revised: 12/2019

Document Id: 98d247f8-64a5-715e-e053-2a95a90a32da

Set id: 2420448e-547d-494b-a2c0-09999ca4eff3

Version: 2

Effective Time: 20191203

Gemini Pharmaceuticals, Inc. dba Plus Pharma