ALUMINA, MAGNESIA, AND 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), DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)

Available from:

VistaPharm, Inc.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Aluminum hydroxide..........................Antacid (equivalent to dried gel, USP) Magnesium hydroxide........................Antacid Simethicone.......................................Antigas relieves: - heartburn - sour stomach - acid indigestion - the symptoms referred to as gas

Product summary:

Alumina, Magnesia, and Simethicone Oral Suspension is a white suspension supplied as follows: NDC 66689-061-01: 30 mL unit-dose cup NDC 66689-061-99: Case contains 100 unit-dose cups of 30 mL (NDC 66689-061-01), packaged in 10 trays of 10 unit-dose cups each. Distributed by: VistaPharm Inc. Largo, FL 33771, USA VP2526 08/20

Authorization status:

OTC monograph final

Summary of Product characteristics

ALUMINA, MAGNESIA, AND SIMETHICONE- ALUMINA, MAGNESIA, AND
SIMETHICONE SUSPENSION
VISTAPHARM, INC.
_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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ALUMINA, MAGNESIA, AND SIMETHICONE ORAL SUSPENSION
MAXIMUM STRENGTH
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_(IN EACH 30 ML DOSE)_
Aluminum hydroxide 2400 mg
(equivalent to dried gel, USP)
Magnesium hydroxide 2400 mg
Simethicone 240 mg
_PURPOSES_
Aluminum hydroxide..........................Antacid
(equivalent to dried gel, USP)
Magnesium hydroxide........................Antacid
Simethicone.......................................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.
Antacid may interact with certain prescription drugs.
WHEN USING THIS PRODUCT
do not take more than 60 mL (2 doses) in a 24-hour period
do not use the maximum dosage for more than 2 weeks except under the
advice
and supervision of a doctor
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help
or contact a
Poison Control Center (1-800-222-1222) right away.
_DIRECTIONS_
shake well before use
adults and children 12 years and older: 30 mL (1 dose) up to 2 times a
day or
as directed by a doctor
children under 12 years of age: ask a doctor
_OTHER INFORMATION_
EACH 30 ML CONTAINS: magnesium 990 mg, sodium 30 mg
store at 20-25°C (68-77°F)
protect from freezing
keep tightly closed
TAMPER-EVIDENT: DO NOT USE IF FOIL ON CUP IS MISSING OR TORN
_INACTIVE INGREDIENTS_
benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor
(contains
alcohol), hypromellose, microcrystalline cellulose, propylparaben,
purified water,
saccharin sodium, sorbitol