NDC 66689-061 Alumina, Magnesia, And Simethicone

Alumina, Magnesia, And Simethicone

NDC Product Code 66689-061

NDC CODE: 66689-061

Proprietary Name: Alumina, Magnesia, And Simethicone What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Alumina, Magnesia, And Simethicone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used for a short time to treat occasional constipation. It is a laxative (osmotic-type) that is thought to work by drawing water into the intestines, an effect that helps to cause movement of the intestines. This medication is also used to treat symptoms caused by too much stomach acid such as heartburn, upset stomach, or indigestion. It is an antacid that works by lowering the amount of acid in the stomach.
  • This medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy). Emollients are substances that soften and moisturize the skin and decrease itching and flaking. Some products (e.g., zinc oxide, white petrolatum) are used mostly to protect the skin against irritation (e.g., from wetness). Dry skin is caused by a loss of water in the upper layer of the skin. Emollients/moisturizers work by forming an oily layer on the top of the skin that traps water in the skin. Petrolatum, lanolin, mineral oil and dimethicone are common emollients. Humectants, including glycerin, lecithin, and propylene glycol, draw water into the outer layer of skin. Many products also have ingredients that soften the horny substance (keratin) that holds the top layer of skin cells together (e.g., urea, alpha hydroxy acids such as lactic/citric/glycolic acid, and allantoin). This helps the dead skin cells fall off, helps the skin keep in more water, and leaves the skin feeling smoother and softer.

NDC Code Structure

  • 66689 - Vistapharm, Inc.
    • 66689-061 - Alumina, Magnesia, And Simethicone

NDC 66689-061-99

Package Description: 100 CUP, UNIT-DOSE in 1 CASE > 30 mL in 1 CUP, UNIT-DOSE (66689-061-01)

NDC Product Information

Alumina, Magnesia, And Simethicone with NDC 66689-061 is a a human over the counter drug product labeled by Vistapharm, Inc.. The generic name of Alumina, Magnesia, And Simethicone is alumina, magnesia, and simethicone. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Vistapharm, Inc.

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.

Alumina, Magnesia, And Simethicone 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 2400 mg/30mL
  • MAGNESIUM HYDROXIDE 2400 mg/30mL
  • DIMETHICONE 240 mg/30mL

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.

  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SORBITOL SOLUTION (UNII: 8KW3E207O2)

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.
  • 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: Vistapharm, Inc.
Labeler Code: 66689
FDA Application Number: part331 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: 09-30-2020 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: 12-31-2021 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.

Alumina, Magnesia, And Simethicone Product Label Images

Alumina, Magnesia, And Simethicone 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

Drug Facts

Active ingredients (in each 30 mL dose)Aluminum hydroxide 2400 mg (equivalent to dried gel, USP)Magnesium hydroxide 2400 mgSimethicone 240 mg

Purposes

Aluminum hydroxide..........................Antacid(equivalent to dried gel, USP)Magnesium hydroxide........................AntacidSimethicone.......................................Antigas

Uses

  • Relieves:heartburnsour stomachacid indigestionthe symptoms referred to as gas

Ask A Doctor Before Use If You Have

  • Kidney diseasea magnesium-restricted diet

When Using This Product

  • Do not take more than 60 mL (2 doses) in a 24-hour perioddo not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

Directions

  • Shake well before use adults and children 12 years and older: 30 mL (1 dose) up to 2 times a day or as directed by a doctor children under 12 years of age: ask a doctor

Other Information

  • Each 30 mL contains: magnesium 990 mg, sodium 30 mgstore at 20-25°C (68-77°F)protect from freezingkeep tightly closedtamper-evident: do not use if foil on cup is missing or torn

Inactive Ingredients

Benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor (contains alcohol), hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

How Supplied

Alumina, Magnesia, and Simethicone Oral Suspension is a white suspension supplied as follows:NDC 66689-061-01: 30 mL unit-dose cupNDC 66689-061-99: Case contains 100 unit-dose cups of 30 mL (NDC 66689-061-01), packaged in 10 trays of 10 unit-dose cups each.Distributed by:VistaPharm Inc.Largo, FL 33771, USAVP252608/20

* Please review the disclaimer below.