ANTACID REGULAR STRENGTH - aluminum hydroxide, magnesium hydroxide and dimethicone 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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Active ingredient (in each 5 mL teaspoon)

Aluminum hydroxide (equiv. to dried gel, USP) 200 mg

Magnesium hydroxide 200 mg

Simethicone 20 mg

Purpose

Antacid

Antigas

Uses

relieves

heartburn
acid indigestion
sour stomach
upset stomach due to 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

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

When using this product

do not exceed 24 teaspoonsful (120 mL) 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 use
adults and children 12 years and older: take 2-4 teaspoonsful (10-20 mL) between meals, at bedtime, or as directed by a doctor
children under 12: ask a doctor

Other information

each teaspoon contains: calcium 25 mg and magnesium 85 mg
does not meet USP requirements for preservative effectiveness
store at 20°-25°C

Inactive ingredients

butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, simethicone emulsion, sorbitol

Principal Display Panel

Regular Strength

Antacid

Antacid/Anti-Gas

Fast Acting

Soothing Relief of

Heartburn

Acid Indigestion

Sour Stomach

Original Flavor

Alcohol 0.2%

Compare to Mylanta® active ingredients

Regular Strength Antacid Front Label

Regular Strength Antacid Back Label

ANTACID REGULAR STRENGTH
aluminum hydroxide, magnesium hydroxide, simethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55312-357
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (ALUMINUM)	ALUMINUM HYDROXIDE	200 mg in 5 mL
MAGNESIUM HYDROXIDE (MAGNESIUM)	MAGNESIUM HYDROXIDE	200 mg in 5 mL
DIMETHICONE (DIMETHICONE)	DIMETHICONE	20 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE
BUTYLPARABEN
CARBOXYMETHYLCELLULOSE SODIUM
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
PROPYLPARABEN
WATER
SORBITOL

Product Characteristics
Color	WHITE (opaque)	Score
Shape		Size
Flavor	MINT (lemon, original)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:55312-357-40	355 mL in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	07/15/1990

Labeler - Western Family Foods Inc (192166072)

Revised: 08/2009 Western Family Foods Inc