LEADER ANTACID MAXIMUM STRENGTH- aluminum hydroxide, magnesium hydroxide and dimethicone liquid 
Cardinal Health

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.

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Active ingredient (in each 5 mL teaspoon)

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg

Magnesium hydroxide 400 mg

Simethicone 40 mg

Purpose

Antacid

Antigas

Uses

relieves

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach due to 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

taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

do not exceed 12 teaspoonsful (60 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 use
  • adults and children 12 years and older: take 2-4 teaspoonsful (10-20 mL) between meals, at bedtime, or as directed by a doctor
  • children under 12: ask a doctor

Other information

  • each teaspoon contains: calcium 50 mg, magnesium 175 mg, potassium 10 mg and sodium 2 mg
  • does not meet USP requirements for preservative effectiveness
  • store at 20°-25°C

Inactive ingredients

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

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Maximum Strength Mylanta® active ingredients

Maximum Strength

Antacid Liquid

Antacid/Anti-Gas

Fast Acting

Soothing Relief of:

Acid Indigestion

Sour Stomach

Heartburn

Classic Original Flavor

Antacid Liquid Front Label

Antacid Liquid Front Label

Antacid Liquid Back Label

Antacid Liquid Back Label

LEADER ANTACID  MAXIMUM STRENGTH
aluminum hydroxide, magnesium hydroxide, simethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-535
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 HYDROXIDE) MAGNESIUM HYDROXIDE400 mg  in 5 mL
DIMETHICONE (DIMETHICONE) DIMETHICONE40 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
BUTYLPARABEN 
CARBOXYMETHYLCELLULOSE SODIUM 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
POTASSIUM CITRATE 
PROPYLPARABEN 
WATER 
SORBITOL 
Product Characteristics
ColorWHITE (opaque) Score    
ShapeSize
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:37205-535-40355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33105/15/1990
Labeler - Cardinal Health (097537435)

Revised: 11/2009
Document Id: 44c8acef-a7c4-439b-9fa5-cf09bcea79f6
Set id: 44c8acef-a7c4-439b-9fa5-cf09bcea79f6
Version: 1
Effective Time: 20091117
 
Cardinal Health