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

----------

DZA Brands, LLC Antacid Drug Facts

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)

340HA-antacid-image1.jpg
340HA-antacid-image2.jpg
HEALTHY ACCENTS ANTACID 
aluminum hydroxide, magnesium hydroxide, simethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-340
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE800 mg  in 10 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE800 mg  in 10 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorWHITE (opaque) Score    
ShapeSize
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-340-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product01/22/200803/24/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33101/22/200803/24/2019
Labeler - DZA Brands LLC (090322194)

Revised: 3/2019
 
DZA Brands LLC