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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Gas Relief Antiflatulent Chewable Tablets

Active Ingredient

(in each chewable tablet)

Simethicone 80 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 6 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 EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

C:\Users\advance\Desktop\word docs - rugby\Simethicone 80 mg-Gas Max\Figure-1.png

NDC 0536-4533-01

Rugby

GAS RELIEF Simethicone 80 mg

ANTIFLATULENT

100 CHEWABLE TABLETS

GAS RELIEF 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-4533
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
SUCROSE (UNII: C151H8M554)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
PEPPERMINT (UNII: V95R5KMY2B)  
SORBITOL (UNII: 506T60A25R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize13mm
FlavorPEPPERMINTImprint Code AP;019
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-4533-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/01/199507/29/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33201/01/199507/29/2018
Labeler - Rugby Laboratories Inc. (079246066)

Revised: 12/2019
Document Id: 81b0d040-e1df-4385-bb0e-be4eb5bee7c1
Set id: 28c3027d-85c0-4242-9b39-617c4d1ff44c
Version: 3
Effective Time: 20191219
 
Rugby Laboratories Inc.