ANTACID MAXIMUM STRENGTH- aluminum hydroxide, magnesium hydroxide, simethicone liquid
Western Family Foods Inc

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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Western Family Antacid Drug Facts

Active ingredients (in each 5 mL = 1 teaspoonful)

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg

Magnesium hydroxide 400 mg

Simethicone 40 mg

Purpose

Antacid

Antigas

Uses

for the relief of

•: acid indigestion
•: heartburn
•: sour stomach
•: upset stomach associated with these symptoms
•: pressure and bloating 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

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

do not exceed 8 teaspoonsful in a 24-hour period, or use the maximum dosage for more than 2 weeks, unless directed by a doctor

Keep out of reach of children.

Directions

•: shake well before using
•: adults and children 12 years and older: take 2 to 4 teaspoonsful two times a day or as directed by a physician
•: do not take more than 8 teaspoonsful in 24 hours or use the maximum dosage for more than 2 weeks
•: children under 12 years: consult a physician

Other information

•: each teaspoonful contains: magnesium 175 mg and sodium 2 mg
•: does not meet USP requirements for preservative effectiveness

Inactive ingredients

butylparaben, flavor, glycerin, hydroxyethyl cellulose, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol, sorbitol solution

Principal Display Panel

Maximum Strength

Antacid

Antacid & Anti-gas

Fast Relief

Heartburn

Acid Indigestion

Pressure

Bloating (gas)

cherry flavor

ALCOHOL 0.1%

Gluten Free

COMPARE TO MAALOX® ADVANCED CHERRY Active Ingredients

ANTACID MAXIMUM STRENGTH
aluminum hydroxide, magnesium hydroxide, simethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55312-588
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	400 mg in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	400 mg in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	40 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
BUTYLPARABEN (UNII: 3QPI1U3FV8)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE (opaque)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55312-588-40	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2006	09/13/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	04/24/2006	09/13/2017

Labeler - Western Family Foods Inc (192166072)

Revised: 11/2017

Document Id: f34bdf3a-6c39-4cd3-a355-bd0372931ca4

Set id: 4f40d29a-e460-4064-9cc7-b55c6df1e228

Version: 3

Effective Time: 20171127

Western Family Foods Inc