LEADER ANTACID MAXIMUM STRENGTH- aluminum hydroxide, magnesium hydroxide, simethicone suspension

Leader Antacid by

Drug Labeling and Warnings

Leader Antacid by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 10 mL)

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

Magnesium hydroxide 800 mg

Simethicone 80 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 take more than 40 mL in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician

Keep out of reach of children.

Directions

• shake well before using
• only use the dose cup provided
• adults and children 12 years and older: take 10 mL to 20 mL two times a day or as directed by a physician
• do not take more than 40 mL in 24 hours or use the maximum dosage for more than 2 weeks
• children under 12 years: consult a physician

Other information

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

Inactive ingredients

butylparaben, flavor, glycerin, hydroxyethyl cellulose, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol, sorbitol solution

Questions?

1-800-719-9260

Principal Display Panel

Advanced Antacid

Maximum Strength

Antacid & Anti-Gas

Fast Relief of

Heartburn

Acid Indigestion

Pressure & Bloating (gas)

SATISFACTION GUARANTEED

Cherry Flavor

ALCOHOL 0.1%

12 FL OZ (355 mL)

INGREDIENTS AND APPEARANCE

LEADER ANTACID  MAXIMUM STRENGTH
aluminum hydroxide, magnesium hydroxide, simethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-536
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	800 mg  in 10 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	800 mg  in 10 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	80 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLPARABEN (UNII: 3QPI1U3FV8)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE (opaque)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-536-40	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/23/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	01/23/2006

Labeler - Cardinal Health (097537435)