NDC 62011-0397 Health Mart Extra Strength Antacid

Calcium Carbonate

NDC Product Code 62011-0397

NDC Code: 62011-0397

Proprietary Name: Health Mart Extra Strength Antacid 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):
ORANGE (C48331)
YELLOW (C48330)
GREEN (C48329)
PINK (C48328 - REDDISH PINK)
Shape: ROUND (C48348)
Size(s):
16 MM
Imprint(s):
G127
Score: 1
Flavor(s):
CHERRY (C73375)
LEMON (C73396)
LIME (C73398)
ORANGE (C73406)

NDC Code Structure

  • 62011 - Mckesson
    • 62011-0397 - Health Mart Extra Strength Antacid

NDC 62011-0397-1

Package Description: 96 TABLET, CHEWABLE in 1 BOTTLE

NDC Product Information

Health Mart Extra Strength Antacid with NDC 62011-0397 is a a human over the counter drug product labeled by Mckesson. The generic name of Health Mart Extra Strength Antacid is calcium carbonate. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Mckesson

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.

Health Mart Extra Strength Antacid 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 750 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.

  • ADIPIC ACID (UNII: 76A0JE0FKJ)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
  • DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • SUCROSE (UNII: C151H8M554)
  • TALC (UNII: 7SEV7J4R1U)
  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • D&C RED NO. 30 (UNII: 2S42T2808B)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

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: Mckesson
Labeler Code: 62011
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: 06-05-2019 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.

Information for Patients



is


...
[Read More]
Calcium Carbonate

Calcium Carbonate is pronounced as (kal' see um) (kar' bon ate)
Why is calcium carbonate medication prescribed?
Calcium carbonate is a dietary supplement used when the amount of calcium taken in the diet is not enough. Calcium is needed by the body for healthy bones, muscles, nervo...
[Read More]

* Please review the disclaimer below.

Health Mart Extra Strength Antacid Product Label Images

Health Mart Extra Strength Antacid 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 750 mg

Purpose

Antacid

Use(S)

  • Relieves:acid indigestionheartburn

Warnings

.

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 10 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

If Pregnant Or/Breastfeeding,

Ask a health professional before use.

Keep Out Of Reach Of Children

.

Directions

  • Adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor.

Other Information

  • Each tablet contains: elemental calcium 300 mgdo not use if printed seal under cap is torn or missing.  store at room temperature. Keep the container tightly closed.

Inactive Ingredients

Adipic acid, corn starch, crospovidone, D&C red 27 lake, D&C red 30 lake, D&C yellow 10 lake, dextrose, FD&C blue 1 lake, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

* Please review the disclaimer below.

Previous Code
62011-0396
Next Code
62011-0398