RUGBY GAS RELIEF ANTIFLATULENT 80 MG EACH- simethicone tablet, chewable 
RUGBY LABORATORIES

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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Rugby Gas Relief Tablets

Drug Facts

Active ingredient (in each chewable tablet)

Simethicone 80 mg, USP

Purpose

Antiflatulent

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 reach of children.

Directions

  • Adults: Chew 1 or 2 tablets as needed after meals and at bedtime
  • Do not exceed 6 tablets in 24 hours except under the advice and supervision of a physician

Other information

  • Store at room temperature
  • Protect from moisture

Inactive ingredients Fructose, Maltodextrin, Natural and Artificial Spearmint Flavor, Silicon Dioxide, Sorbitol, Starch and Stearic Acid.

Questions or Comments

Call 1-800-645-2158

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152

www.rugbylaboratories.com

Rugby®

NDC 0536-1019-01

LACTOSE FREE

GAS RELIEF

Simethicone 80 mg Each

ANTIFLATULENT

100 CHEWABLE TABLETS

0536-1019-01

RUGBY GAS RELIEF  ANTIFLATULENT 80 MG EACH
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1019
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
FRUCTOSE (UNII: 6YSS42VSEV)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SORBITOL (UNII: 506T60A25R)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (uncoated) Scoreno score
ShapeROUND (Round Flat Faced Beveled Edge) Size13mm
FlavorSPEARMINT (Natural and Artificial) Imprint Code GPI;LB
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1019-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/201407/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33208/25/201407/31/2020
Labeler - RUGBY LABORATORIES (079246066)

Revised: 1/2019
Document Id: 7f6b64d0-b0f8-4d15-e053-2a91aa0a552e
Set id: b1a39527-8645-4255-b841-23471b2a2ff3
Version: 4
Effective Time: 20190114
 
RUGBY LABORATORIES