NDC 30142-639 Regular Strength Antacid Mint

Aluminum Hydroxide, Magnesium Hydroxide, Dimethicone

NDC Product Code 30142-639

NDC CODE: 30142-639

Proprietary Name: Regular Strength Antacid Mint 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: Aluminum Hydroxide, Magnesium Hydroxide, Dimethicone 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.

Product Characteristics

Flavor(s):
MINT (C73404)

NDC Code Structure

  • 30142 - Kroger Company

NDC 30142-639-12

Package Description: 355 mL in 1 BOTTLE

NDC Product Information

Regular Strength Antacid Mint with NDC 30142-639 is a a human over the counter drug product labeled by Kroger Company. The generic name of Regular Strength Antacid Mint is aluminum hydroxide, magnesium hydroxide, dimethicone. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Kroger Company

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.

Regular Strength Antacid Mint 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.

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

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: Kroger Company
Labeler Code: 30142
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: 03-01-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Regular Strength Antacid Mint Product Label Images

Regular Strength Antacid Mint 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 Dose)

Aluminum hydroxide 400 mg (equivalent to dried gel, USP)

Magnesium hydroxide 400 mg

Simethicone 40 mg

Purposes

AntacidAntigas

Uses

  • Relievesheartburnsour stomachacid indigestionthe symptoms referred to as gas

Warnings

Do not take more than 80 mL (8 doses) in a 24 hour period or use the maximum dosage for more than 2 weeks
.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.If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • Shake well before useadults and children 12 years and older: take 10 mL to 20 mL (1 to 2 doses) four times a day or as directed by a doctor.children under under 12 years: ask a doctormeasure with dosing cup providedmL=milliliter

Other Information

  • Each 10 mL dose contains: magnesium 165 mg, sodium 6 mg
  • Protect from freezingstore at room temperaturekeep tightly closed

Inactive Ingredients

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

* Please review the disclaimer below.