NDC 0904-6764 Mintox

Aluminum Hydroxide, Magnesium Hydroxide, Simethicone

NDC Product Code 0904-6764

NDC 0904-6764-14

Package Description: 355 mL in 1 BOTTLE

NDC Product Information

Mintox with NDC 0904-6764 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Mintox is aluminum hydroxide, magnesium hydroxide, simethicone. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Major Pharmaceuticals

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Mintox Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ALUMINUM HYDROXIDE 400 mg/10mL
  • MAGNESIUM HYDROXIDE 400 mg/10mL
  • DIMETHICONE 40 mg/10mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Major Pharmaceuticals
Labeler Code: 0904
FDA Application Number: part332 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 12-24-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Aluminum Hydroxide and Magnesium Hydroxide

Aluminum Hydroxide and Magnesium Hydroxide is pronounced as (a loo' mi num) (hye drox' ide) (mag nee' zhum) (hye drox' ide)

Why is aluminum hydroxide and magnesium hydroxide medication prescribed?
Aluminum Hydroxide, Magnesium Hydroxide are antacids used together to relieve heartburn, acid indigestion, and upset stomach. They may be used to treat these symptoms in ...
[Read More]
Simethicone

Simethicone is pronounced as (sye meth' i kone)
Why is simethicone medication prescribed?
Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating.This medication is sometimes prescribed for other uses;...
[Read More]

* Please review the disclaimer below.

Mintox Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients (In Each 10 Ml)

Aluminum hydroxide (equiv. to dried gel, USP) 400 mgMagnesium hydroxide 400 mgSimethicone 40 mg

Purpose

AntacidAntigas

Uses

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

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

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

* Please review the disclaimer below.