PLUS PHARMA- simethicone tablet, chewable

Plus Pharma by

Drug Labeling and Warnings

Plus Pharma by is a Otc medication manufactured, distributed, or labeled by Gemini Pharmaceuticals, Inc. dba Plus Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

OTHER SAFETY INFORMATION

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

INGREDIENTS AND APPEARANCE

PLUS PHARMA 
simethicone tablet, chewable

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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

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

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