Topcare Antacid Maximum Strength

Dosage form: liquid
Ingredients: ALUMINUM HYDROXIDE 400mg in 5mL, MAGNESIUM HYDROXIDE 400mg in 5mL, DIMETHICONE 40mg in 5mL
Labeler: Topco Associates LLC
NDC Code: 36800-588

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) 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 exceed 8 teaspoonsful 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 two times a day or as directed by a physician
do not take more than 8 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 175 mg and sodium 2 mg
does not meet USP requirements for preservative effectiveness

Inactive ingredients

butylparaben, flavor, glycerin, hydroxyethyl cellulose, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol, sorbitol solution

Questions or comments?

1-888-423-0139

Principal Display Panel

MAXIMUM STRENGTH

Antacid

Advanced

ANTACID & ANTIGAS

Fast relief of:

Heartburn

Acid indigestion

Pressure

Bloating (gas)

CHERRY FALVORED LIQUID

ALCOHOL 0.1%

COMPARE TO MAALOX® ADVANCED active ingredients

TOPCARE ANTACID  MAXIMUM STRENGTH
aluminum hydroxide, magnesium hydroxide, simethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-588
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE400 mg  in 5 mL
MAGNESIUM HYDROXIDE (MAGNESIUM CATION and HYDROXIDE ION) MAGNESIUM HYDROXIDE400 mg  in 5 mL
DIMETHICONE (DIMETHICONE) DIMETHICONE40 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN 
GLYCERIN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SACCHARIN SODIUM 
SORBITOL 
SILICON DIOXIDE 
Product Characteristics
ColorWHITE (opaque) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-588-40355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33204/28/2006
Labeler - Topco Associates LLC (006935977)

Revised: 01/2013
 
Topco Associates LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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