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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0), MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P), DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)

Available from:

DZA Brands LLC

INN (International Name):

ALUMINUM HYDROXIDE

Composition:

ALUMINUM HYDROXIDE 400 mg in 10 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antacid Antigas for the relief of

Authorization status:

OTC monograph final

Summary of Product characteristics

HEALTHY ACCENTS MALDROXAL- 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._
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DZA BRANDS, LLC MALDROXAL® DRUG FACTS
ACTIVE INGREDIENTS (IN EACH 10 ML)
Aluminum hydroxide (equiv. to dried gel, USP) 400 mg
Magnesium hydroxide 400 mg
Simethicone 40 mg
PURPOS E
Antacid
Antigas
US ES
for the relief of
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WARNINGS
ASK A DOCTOR BEFORE USE IF YOU HAVE
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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 take more than 80 mL in a 24-hour period, or use the maximum
dosage for more than 2 weeks,
except under the advice and supervision of a physician
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
acid indigestion
heartburn
sour stomach
upset stomach associated with these symptoms
pressure and bloating commonly referred to as gas
kidney disease
a magnesium-restricted diet
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OTHER INFORMATION
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INACTIVE INGREDIENTS
butylparaben, flavor, hypromellose, microcrystalline cellulose and
carboxymethylcellulose sodium,
peppermint oil, propylparaben, purified water, saccharin sodium,
simethicone emulsion, sorbitol,
sorbitol solution
QUESTIONS OR COMMENTS?
1-866-322-2439
PRINCIPAL DISPLAY PANEL
advanced regular strength
maldroxal®
antacid plus antigas
fast relief of:
heartburn
acid indigestion
pressure & bloating (gas)
Compare to Maalox® Advanced Regular Strength active ingredients
cooling mint flavor
12 FL OZ (355 mL)
NO GLUTEN
shake well before using
only use the dose cup provided
adults and children 12 years and older: take 10 mL to 20 mL four times
a day or as directed by a
physician
do not take more than 80 mL in 24 hours or use the maximum dosage for
more than 2 weeks
children under 12 years: consult a physician
each