NDC 27854-120 Belmora Melox Agrura

Calcium Carbonate

NDC Product Code 27854-120

NDC Code: 27854-120

Proprietary Name: Belmora Melox Agrura 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: Calcium Carbonate 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

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
11 MM
Imprint(s):
AZ;036
Score: 1

NDC Code Structure

  • 27854 - Belmora, Llc

NDC 27854-120-01

Package Description: 50 PACKET in 1 CARTON > 2 TABLET, CHEWABLE in 1 PACKET

NDC Product Information

Belmora Melox Agrura with NDC 27854-120 is a a human over the counter drug product labeled by Belmora, Llc. The generic name of Belmora Melox Agrura is calcium carbonate. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Belmora, Llc

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

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.

Belmora Melox Agrura 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.

  • CALCIUM CARBONATE 420 mg/1

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.

  • CROSCARMELLOSE (UNII: 029TFK992N)
  • SORBITOL (UNII: 506T60A25R)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • ASPARTAME (UNII: Z0H242BBR1)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)

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: Belmora, Llc
Labeler Code: 27854
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: 06-03-2019 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.

Belmora Melox Agrura Product Label Images

Belmora Melox Agrura 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 Ingredient (In Each Tablet)

Calcium Carbonate 420 mg

Purpose

Antacid

Uses

For the relief of the following symptoms■ acid indigestion■ sour stomach■ heartburn■ upset stomach associated with these symptoms

Do Not Use

■ the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a

physician or take more than 19 tablets in a 24 hour period.

Ask A Doctor Or Pharmacist Before Use If You Are

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

Stop Use And Ask A Doctor If

■ symptoms last more than 2 weeks

If Pregnant Or Breast Feeding,

Ask a health professional before use.

Directions


do not use more than directed■ chew or crush tablets completely before swallowing■ do not swallow tablets wholeAdults and children: (12 years and older) Chew 2 tablets every 2 or 3 hours as symptoms occur or as

directed by a physician. Do not exceed 19 tablets in 24 hours.
Children under 12 years: Do not give to children under 12 years of age.

Other Information

■ phenylketonurics: may contain phenylalanine 1.5 mg per tablet■ each tablet contains 168 mg of elemental calcium■ store at room temperature 59-86ºF (15-30ºC) in a dry place■ tamper-evident sealed packets■ do not use any opened or torn packets

Inactive Ingredients

Aspartame, croscarmellose sodium, magnesium stearate, maltodextrin, mineral oil, sorbitol

Belmora Melox

NDC 27854-120-01Belmora LLCMeloxAgrura/HeartburnChew or Crush Tablets Completely Before SwallowingMasticar o Triturar Completamente Las Tabletas Antes De TragarAntacid/Calcium CarbonateAntiacido/Carbonato De CalcioHeartburn, IndigestionCalcium Carbonate 420MGLas Aguras, La IndigestionCarbonato De Calco 420MG100 Tablets/50-Dual Packets/1 Tablets per PacketTamper Evident Unit Dose Packets/Empacquetado con Sellado Evidente en Dosis Unitarias

* Please review the disclaimer below.