NDC 0054-3117 Calcium Carbonate

Calcium Carbonate

NDC Product Code 0054-3117

NDC CODE: 0054-3117

Proprietary Name: Calcium Carbonate 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.

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 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. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

NDC Code Structure

  • 0054 - West-ward Pharmaceuticals Corp.

NDC 0054-3117-63

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

Calcium Carbonate with NDC 0054-3117 is a a human over the counter drug product labeled by West-ward Pharmaceuticals Corp.. The generic name of Calcium Carbonate is calcium carbonate. The product's dosage form is suspension and is administered via oral form.

Labeler Name: West-ward Pharmaceuticals Corp.

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.

Calcium Carbonate 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 1250 mg/5mL

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.

  • SORBITOL (UNII: 506T60A25R)
  • 1-PROPOXY-2-PROPANOL (UNII: 152BY1743W)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • SPEARMINT (UNII: J7I2T6IV1N)
  • SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)

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: West-ward Pharmaceuticals Corp.
Labeler Code: 0054
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: 11-18-2004 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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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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Calcium Carbonate Product Label Images

Calcium Carbonate 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

Calcium Carbonate Oral Suspension (Not Usp)

Calcium Supplement

Supplement Facts

Serving Size: 5 mL (teaspoonful)Amount Per Serving% Daily ValueCalcium 500 mg50 %

Active Ingredient

Each 5 mL (teaspoonful) delivers 1250 mg calcium carbonate (equivalent to 500 mg elemental calcium).

Purpose

Antacid

Keep Out Of Reach Of Children

Keep bottle tightly closed. Store in a cool, dry place, out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Uses

Use for the prevention of calcium deficiency in adults.

Warnings

Do not use more than directed.As with any supplement, if you are pregnant or nursing a baby, contact your healthcare professional before use.The seal of the package bears our name, Roxane. If the seal is broken or our name does not appear, do not use.

Directions

Shake well before using. Take 5 mL (one teaspoonful) two to three times daily with meals or as directed by a physician.

Storage And Handling

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep from freezing.Sodium content: 0 mg per 5 mL

Inactive Ingredients

Methylparaben, propylene glycol, propylparaben, purified water, sodium hypochlorite solution, sorbitol solution, spearmint flavor, xanthan gum.

* Please review the disclaimer below.