HEALTHY ACCENTS MALDROXAL - aluminum hydroxide, magnesium hydroxide and dimethicone liquid
DZA Brands LLC

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

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

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

When using this product

do not exceed 16 teaspoonsful (80 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 using
adults and children 12 years and older: take 2-4 tsp (10-20 mL) up to 4 times a day or as directed by a doctor
children under 12: ask a doctor

Other information

each teaspoon contains: calcium 25 mg and magnesium 85 mg
store at 20°-25°C (68°-77°F)
does not meet USP requirements for preservative effectiveness

Inactive ingredients

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

Questions or comments?

1-866-322-2439

Principal Display Panel

regular strength

maldroxal®

antacid plus anti-gas

fast relief from:

heartburn

acid indigestion

sour stomach

Compare to Maalox® active ingredients

cooling mint

Maldroxal Front Label

Maldroxal Back Label

HEALTHY ACCENTS MALDROXAL
aluminum hydroxide, magnesium hydroxide, simethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55316-851
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE)	ALUMINUM HYDROXIDE	200 mg in 5 mL
MAGNESIUM HYDROXIDE (MAGNESIUM HYDROXIDE)	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
SACCHARIN SODIUM
SORBITOL

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

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:55316-851-40	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	01/29/2008

Labeler - DZA Brands LLC (090322194)

Revised: 10/2011 DZA Brands LLC