MINTOX- aluminum hydroxide, magnesium hydroxide, simethicone suspension

mintox by

Drug Labeling and Warnings

mintox by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. 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

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 80 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 four times a day or as directed by a physician
• do not take more than 80 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 175 mg
• does not meet USP requirements for preservative effectiveness
• store at 20-25ºC (68-77ºF)
• protect from freezing

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?

1-800-616-2471

Principal Display Panel

Regular Strength

Mintox™

Antacid/Antigas

Aluminum Hydroxide

Magnesium Hydroxide

Simethicone

Fast Relief of:

Heartburn

Acid Indigestion

Pressure and Bloating

Mint Flavor

12 FL OZ (355 mL)

INGREDIENTS AND APPEARANCE

MINTOX 
aluminum hydroxide, magnesium hydroxide, simethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6764
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
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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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: 0904-6764-14	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/24/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	12/24/2018

Labeler - Major Pharmaceuticals (191427277)