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

Rugby Gas Relief by

Drug Labeling and Warnings

Rugby Gas Relief by is a Otc medication manufactured, distributed, or labeled by RUGBY LABORATORIES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each chewable tablet)

Simethicone 80 mg, USP

PURPOSE

Purpose

Antiflatulent

INDICATIONS & USAGE

Uses relieves bloating and pressure commonly referred to as gas.

WARNINGS

Warnings

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information

• Store at room temperature
• Protect from moisture
  

INACTIVE INGREDIENT

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

QUESTIONS

Questions or Comments

Call 1-800-645-2158

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

Rugby®

NDC: 0536-1019-01

LACTOSE FREE

GAS RELIEF

Simethicone 80 mg Each

ANTIFLATULENT

100 CHEWABLE TABLETS

INGREDIENTS AND APPEARANCE

RUGBY GAS RELIEF  ANTIFLATULENT 80 MG EACH
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1019
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	80 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	no score
Shape	ROUND (Round Flat Faced Beveled Edge)	Size	13mm
Flavor	SPEARMINT (Natural and Artificial)	Imprint Code	GPI;LB
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1019-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/25/2014	07/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	08/25/2014	07/31/2020

Labeler - RUGBY LABORATORIES (079246066)