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Gas Relief by Rugby Laboratories Inc.

Medically reviewed on December 6, 2017

Dosage form: tablet, chewable
Ingredients: SIMETHICONE 125mg
Labeler: Rugby Laboratories Inc.
NDC Code: 0536-4534

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.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-4534
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE 
SUCROSE 
MALTODEXTRIN 
PEPPERMINT 
SORBITOL 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize16mm
FlavorPEPPERMINTImprint CodeAP;040
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-4534-0860 TABLET, CHEWABLE (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33210/16/1995
Labeler - Rugby Laboratories Inc. (191427277)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIOperations
Advance Pharmaceutical Inc.078301063MANUFACTURE(0536-4534)

 
Rugby Laboratories Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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