LEADER ANTACID MAXIMUM STRENGTH- aluminum hydroxide, magnesium hydroxide, simethicone suspension 
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 Liquid Drug Facts

Active ingredients (in each 10 mL)

Aluminum hydroxide (equiv. to dried gel, USP) 800 mg

Magnesium hydroxide 800 mg

Simethicone 80 mg

Purposes

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

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

When using this product

do not exceed 60 mL in a 24-hour period, or use the maximum dosage for more than 2 weeks

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

•
shake well before use
•
measure with dosing cup provided
•
adults and children 12 years and over: 10 mL – 20 mL between meals, at bedtime or as directed by a doctor
•
do not take more than 60 mL in any 24 hour period
•
do not use the maximum dosage for more than 2 weeks
•
children under 12 years: ask a doctor
•
mL = milliliter

Other information

•
each 10 mL contains: magnesium 350 mg, potassium 20 mg and sodium 3 mg
•
does not meet USP requirements for preservative effectiveness
•
store at 20-25°C (68-77°F), do not freeze

Inactive ingredients

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

Questions?

1-800-719-9260

Principal Display Panel

Compare to Mylanta® Maximum Strength active ingredients

MAXIMUM STRENGTH

Antacid Liquid

Antacid/Anti-Gas

FastActing

Soothing Relief of:

Acid Indigestion – Sour Stomach

Heartburn

Classic Original Flavor

SATISFACTION GUARANTEED

12 FL OZ (355 mL)

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340E9-antacid-image2.jpg
LEADER ANTACID  MAXIMUM STRENGTH
aluminum hydroxide, magnesium hydroxide, simethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-535
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE800 mg  in 10 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P, MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE800 mg  in 10 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorWHITE (opaque) Score    
ShapeSize
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-535-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/199006/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33105/15/199006/30/2021
Labeler - Cardinal Health (097537435)

Revised: 11/2021
Document Id: 5c79a4ce-dbc0-4e05-a3c6-5e44428d8834
Set id: 44c8acef-a7c4-439b-9fa5-cf09bcea79f6
Version: 5
Effective Time: 20211111
 
Cardinal Health