LEADER ANTACID- 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 110, LLC. dba Leader. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 10 mL)

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

Magnesium hydroxide 400 mg

Simethicone 40 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 120 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.

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 120 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 175 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, peppermint oil, propylparaben, purified water, simethicone emulsion, sorbitol, sorbitol solution

Questions or comments?

1-800-719-9260

Principal Display Panel

Regular Strength

Antacid Liquid

Aluminum Hydroxide | Magnesium Hydroxide

Simethicone | Antacid | Antigas

Original Flavor

ALCOHOL 0.2%

Fast Relief of:

Heartburn

Acid Indigestion

Pressure & Bloating

100% Money Back Guarantee

12 FL OZ (355 mL)

INGREDIENTS AND APPEARANCE

LEADER ANTACID 
aluminum hydroxide, magnesium hydroxide, simethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0476
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	400 mg  in 10 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	400 mg  in 10 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	40 mg  in 10 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)
SORBITOL (UNII: 506T60A25R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0476-1	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/05/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	03/05/2019

Labeler - Cardinal Health (097537435)