GELUSIL- aluminum hydroxide magnesium hydroxide simethicone tablet, chewable
WellSpring Pharmaceutical Corporation

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.

----------

Gelusil Tablets

Active Ingredients (in each tablet)

Aluminum hydroxide dried gel 200 mg
Magnesium hydroxide 200 mg
Simethicone 25 mg

Purpose

Active ingredients (in each tablet) Purpose
Aluminum hydroxide dried gel 200 mg........................Antacid
Magnesium hydroxide 200 mg.....................................Antacid
Simethicone 25 mg......................................................Antigas

Uses

Relieves:

heartburn
acid indigestion
sour stomach
upset stomach due to these symptoms
relieves symptoms referred to as gas

Warnings

Ask a doctor before use if you have

kidney disease
a magnesium restricted diet

Ask a doctor or pharmacist before use if

you are now taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if

symproms last more than 2 weeks

Keep out of reach of children.

Directions

Chew 2 to 4 tablets. Repeat hourly if symptoms return, or as directed by a physician.
Do not take more than 12 tablets in a 24-hour period, or use the maximum dosage for more than 2 weeks

Other information

each tablet contains: magnesium 95 mg
store at 59º to 77º (15º to 25ºC)
do not use if blister or printed Gelusil foil seal is broken
see side panel for lot number and expiration date

Inactive ingredients

flavors, magnesium stearate, mannitol, saccharin sodium, sorbitol, and sugar

Questions?

Call 1.866.337.4500

WellSpring Pharmaceutical Corporation
SARASOTA, FL 34243 USA
©WellSpring 2013 Made in Canada

Package Label

Carton

GELUSIL
aluminum hydroxide magnesium hydroxide simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65197-300
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	200 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	24 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	200 mg
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	1 mg

Ingredient Name	Strength
Inactive Ingredients
MANNITOL (UNII: 3OWL53L36A)
RAW SUGAR (UNII: 8M707QY5GH)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	16mm
Flavor	PEPPERMINT	Imprint Code	PD;GELUSIL;034
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65197-300-20	2 in 1 CARTON	07/17/2012	09/30/2016
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part331	07/17/2012	09/30/2016

Labeler - WellSpring Pharmaceutical Corporation (110999054)

Revised: 8/2014

Document Id: 87e19f8e-57ae-40b9-ba8f-6003339748e5

Set id: bddf72bf-985e-45c7-b37a-026687fa5fd1

Version: 8

Effective Time: 20140804

WellSpring Pharmaceutical Corporation