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

C:\Users\advance\Desktop\word docs - rugby\Simethicone 125 mg-Gas Max\Figure-1.png

NDC: 0536-4534-08

Rugby

MAXIMUM STRENGTH GAS RELIEF Simethicone 125 mg

ANTIFLATULENT

60 CHEWABLE TABLETS

GAS RELIEF 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0536-4534
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 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
ShapeROUNDSize16mm
FlavorPEPPERMINTImprint Code AP;040
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0536-4534-0860 in 1 BOTTLE; Type 0: Not a Combination Product10/16/199507/29/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33210/16/199507/29/2018
Labeler - Rugby Laboratories Inc. (079246066)

Revised: 12/2019
 
Rugby Laboratories Inc.