Maalox Antacid: Package Insert and Label Information

MAALOX ANTACID — aluminum hydroxide, magnesium hydroxide and dimethicone liquid
Physicians Total Care, 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.

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
(click image for full-size original)

image of package label
MAALOX ANTACID
aluminum hydroxide, magnesium hydroxide, simethicone liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-2093(NDC:0113-0851)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE 200 mg in 5 mL
MAGNESIUM HYDROXIDE (MAGNESIUM HYDROXIDE) MAGNESIUM HYDROXIDE 200 mg in 5 mL
DIMETHICONE (DIMETHICONE) DIMETHICONE 20 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
BUTYLPARABEN
CARBOXYMETHYLCELLULOSE SODIUM
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
PROPYLPARABEN
WATER
SACCHARIN SODIUM
SORBITOL
Product Characteristics
Color WHITE (opaque) Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-2093-0 355 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part332 12/12/2006
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 01/2012 Physicians Total Care, Inc.

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