Mintox: Package Insert and Label Information

MINTOX- aluminum hydroxide, magnesium hydroxide and dimethicone suspension
Major Pharmaceuticals

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.

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)

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(click image for full-size original)
MINTOX
aluminum hydroxide, magnesium hydroxide, simethicone suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6764
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE 400 mg in 10 mL
MAGNESIUM HYDROXIDE (MAGNESIUM CATION and HYDROXIDE ION) MAGNESIUM HYDROXIDE 400 mg in 10 mL
DIMETHICONE (DIMETHICONE) DIMETHICONE 40 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLPARABEN
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
CARBOXYMETHYLCELLULOSE SODIUM
PEPPERMINT OIL
PROPYLPARABEN
WATER
SACCHARIN SODIUM
SORBITOL
SILICON DIOXIDE
Product Characteristics
Color WHITE (opaque) Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-6764-14 355 mL in 1 BOTTLE None
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)

Revised: 07/2019 Major Pharmaceuticals

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