Maalox Antacid
FDA Label NDC 54868-2093

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Maalox Antacid (NDC 54868-2093). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each 5 ml teaspoon), purpose, uses, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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

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 StrengthLiquid AntacidAntacid & Anti-GasFast Relief of:HeartburnAcid IndigestionSour Stomach & Upset StomachMint FlavorMaalox Antacid     12 fl oz (355 mL)NDC 54868-2093-0

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