TOPCARE ANTACID- aluminum hydroxide, magnesium hydroxide and dimethicone liquid 
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.

----------

Topco Associates LLC. Antacid Drug Facts

Active ingredients (in each 5 mL = 1 teaspoonful)

Aluminum hydroxide (equiv. to dried gel, USP) 200 mg

Magnesium hydroxide 200 mg

Simethicone 20 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 exceed 16 teaspoonsful (80 mL) in a 24-hour period, or use the maximum dosage for more than 2 weeks, unless directed by a doctor

Keep out of reach of children.

Directions

shake well before using
adults and children 12 years and older: take 2 to 4 teaspoonsful (10-20 mL) four times a day or as directed by a physician
do not take more than 16 teaspoonsful in 24 hours or use the maximum dosage for more than 2 weeks
children under 12 years: consult a physician

Other information

each teaspoonful contains: magnesium 85 mg
does not meet USP requirements for preservative effectiveness

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 LIQUID

COMPARE TO MAALOX® ADVANCED active ingredients

Antacid Front Label Image
Antacid Back Label Image
TOPCARE ANTACID 
aluminum hydroxide, magnesium hydroxide, simethicone liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-851
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 200 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 200 mg  in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 20 mg  in 5 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
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: 11/2012
Document Id: 73e9527d-1a2e-4259-ad5c-f52c3554359c
Set id: ee2d2f35-66af-4e8d-9494-dbb20cb134b6
Version: 2
Effective Time: 20121105
 
Topco Associates LLC