LEADER ANTACID REGULAR STRENGTH- aluminum hydroxide, magnesium hydroxide, simethicone 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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Cardinal Health Antacid Drug Facts

Active ingredients (in each 5 mL = teaspoonful)

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

presently 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 to 4 teaspoonsful (10-20 mL) 4 times a day or as directed by a physician
•
do not take more than 16 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 85 mg
•
does not meet USP requirements for preservative effectiveness

Inactive ingredients

butylparaben, flavor, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, peppermint oil, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol, sorbitol solution

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Maalox® Advanced active ingredients

Advanced

Antacid

Regular Strength

Antacid & Antigas

Fast Relief of

Heartburn

Acid Indigestion

Pressure & Bloating (gas)

Mint Flavor

Antacid Front Label
Antacid Back Label
LEADER ANTACID  REGULAR STRENGTH
aluminum hydroxide, magnesium hydroxide, simethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-314
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE200 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE200 mg  in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorWHITE (opaque) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-314-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product10/30/200204/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33210/30/200204/30/2021
Labeler - Cardinal Health (097537435)

Revised: 11/2021
Document Id: 27bd3d3d-caf7-4524-934c-e89ad4ca7333
Set id: 2bcacacc-8467-40e9-82f6-a560e69bd055
Version: 4
Effective Time: 20211111
 
Cardinal Health