Maximum Strength Gas Relief Antiflatulent Chewable Tablets

Gas Relief by

Drug Labeling and Warnings

Gas Relief by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories Inc., Advance Pharmaceutical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GAS RELIEF- simethicone tablet, chewable 
Rugby Laboratories Inc.

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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Maximum Strength Gas Relief Antiflatulent Chewable Tablets

Active Ingredient

(in each chewable tablet)

Simethicone 125 mg

Purpose

Antiflatulent

Use

relieves bloating, pressure and fullness commonly referred to as gas

Warnings

Keep out of reach of children.

Directions

• thoroughly chew 1-2 tablets as needed after meals and at bedtime
• do not take more than 4 tablets per day

Other Information

store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

dextrose, dipac sugar, maltodextrin, peppermint flavor, sorbitol, stearic acid

Questions or Comments

Call 1-800-645-2158, 9 am – 5 pm EST, Monday – Friday

•   TAMPER EVIDE NT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 0536-4534-08

Rugby

MAXIMUM STRENGTH GAS RELIEF Simethicone 125 mg

ANTIFLATULENT

60 CHEWABLE TABLETS

GAS RELIEF 
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-4534
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
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
SUCROSE (UNII: C151H8M554)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PEPPERMINT (UNII: V95R5KMY2B)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	16mm
Flavor	PEPPERMINT	Imprint Code	AP;040
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-4534-08	60 in 1 BOTTLE; Type 0: Not a Combination Product	10/16/1995	07/29/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	10/16/1995	07/29/2018

Labeler - Rugby Laboratories Inc. (079246066)

Revised: 12/2019

Document Id: c8cbf2c9-9d34-47e7-8f83-6fb34838b238

34390-5

Set id: d0aecee1-13f9-4d53-bad5-ba7d8266816a

Version: 3

Effective Time: 20191219

 

Rugby Laboratories Inc.