NDC 62011-0229 Healthmart Calcium Antacid

Calcium Carbonate

NDC Product Code 62011-0229

NDC 62011-0229-1

Package Description: 80 TABLET, CHEWABLE in 1 BOTTLE

NDC Product Information

Healthmart Calcium Antacid with NDC 62011-0229 is a a human over the counter drug product labeled by Strategic Sourcing Services Llc. The generic name of Healthmart Calcium Antacid is calcium carbonate. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Strategic Sourcing Services 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.

Healthmart Calcium 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)
  • ASPARTAME (UNII: Z0H242BBR1)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • SORBITOL (UNII: 506T60A25R)

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: Strategic Sourcing Services Llc
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: 10-21-2019 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’.

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Information for Patients



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[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]

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Healthmart Calcium Antacid Product Label Images

Healthmart Calcium 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

Uses

  • Relieves:acid indigestionheartburn

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.keep out of reach of children.

Directions

  • Chew 2-4 tablets as symptoms occur, or as directed by a doctor

Other Information

  • Store at room temperature. Phenylketonurics: contains phenylalanine, less than 1 mg per tablet

Inactive Ingredients

Adipic acid, aspartame, FD&C yellow 6 aluminum lake, flavor, magnesium stearate, maltodextrin, sorbitol

Pdp

Compare to Tums EX Sugar free chewable tablets active ingredientsugar freecalcium antacidcalcium carbonate 750 mg /calcium supplementFast relief of heartburn & acid indigestionDaily source of calciumExtra strengthNatural and Artificial Orange Creme Flavor80 Chewable Tablets

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