HEALTHY ACCENTS ANTACID- aluminum hydroxide, magnesium hydroxide, simethicone suspension

healthy accents antacid by

Drug Labeling and Warnings

healthy accents antacid by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 10 mL)

Aluminum hydroxide (equiv. to dried gel, USP) 800 mg

Magnesium hydroxide 800 mg

Simethicone 80 mg

Purposes

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

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

When using this product

do not exceed 60 mL in a 24-hour period, or use the maximum dosage for 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).

Directions

• shake well before use
• measure with dosing cup provided
• adults and children 12 years and over: 10 mL – 20 mL between meals, at bedtime or as directed by a doctor
• do not take more than 60 mL in any 24 hour period
• do not use the maximum dosage for more than 2 weeks
• children under 12 years: ask a doctor
• mL = milliliter

Other information

• each 10 mL contains: magnesium 350 mg, potassium 20 mg and sodium 3 mg
• does not meet USP requirements for preservative effectiveness
• store at 20-25°C (68-77°F), do not freeze

Inactive ingredients

butylparaben, flavor, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, potassium citrate, propylparaben, purified water, simethicone emulsion, sorbitol, sorbitol solution

Questions or comments?

1-866-322-2439

Principal Display Panel

maximum strength

antacid

plus anti-gas

fast acting

antacid - anti-gas

heartburn

acid indigestion

sour stomach

Compare to Mylanta® Maximum Strength active ingredients

original flavor

NO GLUTEN

12 FL OZ (355mL)

INGREDIENTS AND APPEARANCE

HEALTHY ACCENTS ANTACID 
aluminum hydroxide, magnesium hydroxide, simethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-340
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	800 mg  in 10 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	800 mg  in 10 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	80 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-340-40	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/22/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	01/22/2008

Labeler - DZA Brands LLC (090322194)