LEADER ANTACID REGULAR STRENGTH- aluminum hydroxide, magnesium hydroxide, simethicone liquid

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 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

INGREDIENTS AND APPEARANCE

LEADER ANTACID  REGULAR STRENGTH
aluminum hydroxide, magnesium hydroxide, simethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-314
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	200 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	200 mg  in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
PEPPERMINT OIL (UNII: AV092KU4JH)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-314-40	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/30/2002

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	10/30/2002

Labeler - Cardinal Health (097537435)