TOPCARE ANTACID- aluminum hydroxide, magnesium hydroxide, simethicone suspension 
Topco Associates 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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Topco Associates LLC. Antacid Drug Facts

Active ingredients (in each 10 mL)

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg

Magnesium hydroxide 400 mg

Simethicone 40 mg

Purpose

Antacid

Antigas

Uses

for the relief of

acid indigestion
heartburn
sour stomach
upset stomach associated with 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 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

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

Other information

each 10 mL contains: magnesium 175 mg
does not meet USP requirements for preservative effectiveness
store at 20-25ºC (68-77ºF)
protect from freezing

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?

1-888-423-0139

Principal Display Panel

REGULAR STRENGTH

Antacid Advanced

ANTACID & ANTIGAS

Fast relief of:

Heartburn

Acid indigestion

Pressure

Bloating (gas)

MINT FLAVORED

QUALITY GUARANTEED

COMPARE TO MAALOX® ADVNACED active ingredients

12 FL OZ (355 mL)

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TOPCARE ANTACID 
aluminum hydroxide, magnesium hydroxide, simethicone suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-851
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 400 mg  in 10 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 400 mg  in 10 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 40 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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
Product Characteristics
Color WHITE (opaque) Score     
Shape Size
Flavor MINT Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:36800-851-40 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/03/2002
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part332 12/03/2002
Labeler - Topco Associates LLC (006935977)

Revised: 8/2017
Document Id: 791e39c7-2b76-49c8-a6fe-3407a90932ee
Set id: ee2d2f35-66af-4e8d-9494-dbb20cb134b6
Version: 3
Effective Time: 20170816
 
Topco Associates LLC