OTC Medication Information: Gelusil

GELUSIL- aluminum hydroxide, magnesium hydroxide, dimethicone and silicon dioxide 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.

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
sour stomach
acid indigestion
bloating, pressure and discomfort commonly 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

symptoms last more than 2 weeks

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away 1.800.222.1222

If pregnant or breastfeeding

ask a health professional before use.

Directions

For adults and children 12 years of age and older: Chew 2 to 4 tablets. Repeat hourly if symptoms return, or as directed by a physician
Children under 12: ask a doctor
Do not take more than 12 tablets in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician

Other information

Each tablet contains: magnesium 95 mg
Store below 30°C (86°F)
Tamper Evident. Do not use if blister or printed Gelusil foil seal is broken
See end panel for lot number and expiration date

Inactive ingredients

Dextrose, flavors, magnesium stearate, maltodextrin, microcrystalline cellulose, silica, sucralose

Questions?

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© WellSpring 2018

Sarasota, FL 34243 USA

Made in USA

Principal display panel — Carton

Gelusil Antacid Antigas 10 Blister

Gelusil Antacid 100 Chewable Tablets

Gelusil Antacid Antigas Cool mint 100 Chewable TabletsGelusil Antacid Antigas Cool mint 100 Chewable TabletsGelusil Antacid Antigas 10 Blister
GELUSIL
alumina, magnesia, simethicone tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65197-300
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE 200 mg
MAGNESIUM HYDROXIDE (MAGNESIUM CATION) MAGNESIUM HYDROXIDE 200 mg
DIMETHICONE (DIMETHICONE) DIMETHICONE 24 mg
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 1 mg
Inactive Ingredients
Ingredient Name Strength
DEXTROSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MALTODEXTRIN
SUCRALOSE
SILICON
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 16mm
Flavor PEPPERMINT Imprint Code PD;GELUSIL;034
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65197-300-10 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (65197-300-10)
2 NDC:65197-300-11 100 TABLET, CHEWABLE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part331 09/24/2008
Labeler — WellSpring Pharmaceutical Corporation (110999054)

Revised: 10/2019 WellSpring Pharmaceutical Corporation

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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