Major Pharmaceuticals Mintox™

Major Pharmaceuticals Mintox™
SPL v2
SPL
SPL Set ID a60965f7-9b71-45e7-8077-d5c6087c40dd
Route
ORAL
Published
Effective Date 2019-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aluminum Hydroxide (400 mg) Hydroxide Ion (40 mg) Dimethicone
Inactive Ingredients
Butylparaben Hypromelloses Cellulose, Microcrystalline Carboxymethylcellulose Sodium Peppermint Oil Propylparaben Water Saccharin Sodium Sorbitol Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-05-21

Description

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg Magnesium hydroxide 400 mg Simethicone 40 mg

Purpose

Antacid Antigas


Medication Information

Purpose

Antacid

Antigas

Description

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg Magnesium hydroxide 400 mg Simethicone 40 mg

Uses

for the relief of

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
  • pressure and bloating commonly referred to as gas
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

Regluar Strength

Mintox

Antacid/Antigas

Aluminum Hydroxide ■ Magnesium Hydroxide ■ Simethicone

Fast Relief of:

Heartburn

Acid Indigestion

Pressure and Bloating

Mint Flavor

Compare to the active ingredients of Maalox® Advanced

NDC 17856-6764-01

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

Active Ingredients (in Each 10 Ml)

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

Magnesium hydroxide 400 mg

Simethicone 40 mg

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.


Structured Label Content

Uses

for the relief of

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
  • pressure and bloating commonly referred to as gas
Purpose

Antacid

Antigas

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 (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 (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? (Questions or comments?)

1-800-616-2471

Principal Display Panel

Regluar Strength

Mintox

Antacid/Antigas

Aluminum Hydroxide ■ Magnesium Hydroxide ■ Simethicone

Fast Relief of:

Heartburn

Acid Indigestion

Pressure and Bloating

Mint Flavor

Compare to the active ingredients of Maalox® Advanced

NDC 17856-6764-01

When Using This Product (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

Active Ingredients (in Each 10 Ml) (Active ingredients (in each 10 mL))

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

Magnesium hydroxide 400 mg

Simethicone 40 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • kidney disease
  • a magnesium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

presently taking a prescription drug. Antacids may interact with certain prescription drugs.


Advanced Ingredient Data


Raw Label Data

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