ADVANCED ANTACID REGULAR STRENGTH- aluminum hydroxide, magnesium hydroxide, dimethicone liquid

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:

STRATEGIC SOURCING SERVICES LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antacid Antigas relieves - heartburn - sour stomach - acid indigestion - the symptoms referred to as gas

Authorization status:

OTC monograph final

Summary of Product characteristics

ADVANCED ANTACID REGULAR STRENGTH- ALUMINUM HYDROXIDE, MAGNESIUM
HYDROXIDE, DIMETHICONE LIQUID
STRATEGIC SOURCING SERVICES LLC
----------
SUNMARK ANTACID ORIGINAL
ACTIVE INGREDIENTS (IN EACH 5 ML TEASPOONFUL)
Aluminum hydroxide 200mg (equivalent to dried gel, USP)
Magnesium hydroxide 200 mg
Simethicone 20mg
PURPOSES
Antacid
Antigas
USES
relieves
heartburn
sour stomach
acid indigestion
the symptoms 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.
STOP USE AND ASK A DOCTOR IF symptoms last more than 2 weeks
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
shake well before use
adults and children 12 years and older: take 2 to 4 teaspoonfuls
between meals, at
bedtime, or as directed by a doctor
do not take more than 24 teaspoonfuls in 24 hours or use the maximum
dosage for
more than 2 weeks
children under under 12 years: ask a doctor
OTHER INFORMATION
EACH 5 ML TEASPOONFUL CONTAINS: magnesium 85 mg, sodium 1 mg
protect from freezing
store at room temperature
keep tightly closed
INACTIVE INGREDIENTS
benzyl alcohol, butylparaben, flavor (contains alcohol),
hydroxyethylcellulose,
propylparaben, purified water, saccharin sodium, sorbitol solution
PACKAGE LABEL
Sunmark
compare to active ingredients of the Regular Strength Mylanta®*
NDC 49348-153-39
advanced
antacid
Regular Strength
antacid/antigas
Alumina, Magnesia
and Simethicone
Oral Suspension
Fast acting
soothing relief of
heartburn,
acid indigestion,
sour stomach,
pressure & bloating
ORIGINAL FLAVOR
Alcohol 0.15%
12 FL OZ (355 mL)
ADVANCED ANTACID REGULAR STRENGTH
aluminum hydroxide, magnesium hydroxide, dimethicone liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:49348-153
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
ALUMI