Rugby Maximum Strength Gas Relief Tablets

Maximum Strength Gas Relief by

Drug Labeling and Warnings

Maximum Strength Gas Relief by is a Otc medication manufactured, distributed, or labeled by RUGBY LABORATORIES, GEMINI PHARMACEUTICALS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MAXIMUM STRENGTH GAS RELIEF ANTIFLATULENT- 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 Maximum Strength Gas Relief Tablets

Drug Facts

Active ingredient (in each chewable tablet)

Simethicone 125 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 take more than 4 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, stearic acid.

Questions or comments?

Call 1-800-645-2158

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

*Rugby Laboratories is not affiliated with the owner of the registered trademark Gas-X®

COMPARE TO ACTIVE INGREDIENT IN GAS-X® EXTRA STRENGTH*

Rugby®

NDC: 0536-1020-08

LACTOSE FREE

MAXIMUM STRENGTH
GAS RELIEF

Simethicone 125 mg Each

Antiflatulent

60 CHEWABLE TABLETS

Distributed by: Rugby Laboratories

17177 N. Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

MAXIMUM STRENGTH GAS RELIEF  ANTIFLATULENT
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1020
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
FRUCTOSE (UNII: 6YSS42VSEV)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (uncoated)	Score	2 pieces
Shape	ROUND (Flat Faced Beveled Edge)	Size	16mm
Flavor	SPEARMINT (Natural and Artificial)	Imprint Code	G23
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1020-08	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/27/2014	01/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	05/27/2014	01/31/2020

Labeler - RUGBY LABORATORIES (079246066)

Registrant - GEMINI PHARMACEUTICALS INC. (055942270)

Establishment
Name	Address	ID/FEI	Business Operations
GEMINI PHARMACEUTICALS INC.		055942270	manufacture(0536-1020)

Revised: 9/2018

Document Id: 763cfd6e-e818-1cba-e053-2991aa0afb4f

34390-5

Set id: 2b4ce796-b779-434d-9470-1031546b5e81

Version: 3

Effective Time: 20180919

 

RUGBY LABORATORIES