Your browser does not support JavaScript! MAALOX ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [PHYSICIANS TOTAL CARE, INC.]
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MAALOX ANTACID (aluminum hydroxide, magnesium hydroxide, simethicone) liquid
[Physicians Total Care, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient (in each 5 mL teaspoon)

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

now 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 2-4 tsp (10-20 mL) up to 4 times a day or as directed by a doctor
  • children under 12: ask a doctor

Other information

  • each teaspoon contains: calcium 25 mg and magnesium 85 mg
  • store at 20°-25°C (68°-77°F)
  • does not meet USP requirements for preservative effectiveness

Inactive ingredients

butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol

Questions or comments?

1-800-719-9260

Principal Display Panel

Regular Strength

Liquid Antacid

Antacid & Anti-Gas

Fast Relief of:

Heartburn

Acid Indigestion

Sour Stomach & Upset Stomach

Mint Flavor

Maalox Antacid     12 fl oz (355 mL)

NDC 54868-2093-0

image of package label

MAALOX ANTACID 
aluminum hydroxide, magnesium hydroxide, simethicone liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54868-2093(NDC:0113-0851)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE200 mg  in 5 mL
MAGNESIUM HYDROXIDE (MAGNESIUM HYDROXIDE) MAGNESIUM HYDROXIDE200 mg  in 5 mL
DIMETHICONE (DIMETHICONE) DIMETHICONE20 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
BUTYLPARABEN 
CARBOXYMETHYLCELLULOSE SODIUM 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
PROPYLPARABEN 
WATER 
SACCHARIN SODIUM 
SORBITOL 
Product Characteristics
ColorWHITE (opaque) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-2093-0355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33212/12/2006
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 1/2012
 
Physicians Total Care, Inc.

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