NDC 70000-0034 Regular Strength Antacid Assorted Fruit

Calcium Carbonate

NDC Product Code 70000-0034

NDC Code: 70000-0034

Proprietary Name: Regular Strength Antacid Assorted Fruit 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):
RED (C48326)
YELLOW (C48330)
ORANGE (C48331)
GREEN (C48329)
Shape: ROUND (C48348)
Size(s):
16 MM
Imprint(s):
RP101
Score: 1
Flavor(s):
FRUIT (C73389 - ASSORTED)

NDC Code Structure

  • 70000 - Cardinal Health
    • 70000-0034 - Regular Strength Antacid

NDC 70000-0034-1

Package Description: 150 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

NDC Product Information

Regular Strength Antacid Assorted Fruit with NDC 70000-0034 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Regular Strength Antacid Assorted Fruit is calcium carbonate. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Cardinal Health

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.

Regular Strength Antacid Assorted Fruit 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 500 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)
  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

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: Cardinal Health
Labeler Code: 70000
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: 04-16-2019 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



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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]

* Please review the disclaimer below.

Regular Strength Antacid Assorted Fruit 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

Calcium Carbonate USP 500mg

Purpose

Antacid

Uses

  • Relieves: •heartburn •sour stomach •acid indigestion •upset stomach associated with these symptoms

Warnings

  • Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.When using this product •do not take more than 15 tablets in 24 hours •if pregnant do not take more than 10 tablets in 24 hours •do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.

Directions

  • •Adults and children 12 years of age and over: Chew 2-4 tablets completely as symptoms occur, or as directed by a doctor. Do not swallow tablets whole. •Do not take for symptoms that persist for more than 2 weeks unless advised by a doctor.

Other Information

  • •each tablets contains: elemental calcium 200mg •Store at room temperature. Keep the container tightly closedSAFETY SEALED: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Inactive Ingredients

Adipic acid, D&C Red No. 27, D&C Yellow No. 10, dextrose, FD&C Blue No. 1, flavors, magnesium stearate, maltodextrin, starch, sucralose.

* Please review the disclaimer below.

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