NDC 55301-102 Exchange Select Antacid Tropical Fruit

Calcium Carbonate

NDC Product Code 55301-102

NDC Code: 55301-102

Proprietary Name: Exchange Select Antacid Tropical 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):
YELLOW (C48330)
ORANGE (C48331)
WHITE (C48325)
RED (C48326)
Shape: ROUND (C48348)
Size(s):
17 MM
Imprint(s):
RP102
Score: 1
Flavor(s):
FRUIT (C73389 - BANANA, ORANGE, PINEAPPLE, TROPICAL FRUIT PUNCH)

Code Structure
  • 55301 - Army And Air Force Exchange Service
    • 55301-102 - Exchange Select Antacid

NDC 55301-102-34

Package Description: 96 TABLET, CHEWABLE in 1 BOTTLE

NDC Product Information

Exchange Select Antacid Tropical Fruit with NDC 55301-102 is a a human over the counter drug product labeled by Army And Air Force Exchange Service. The generic name of Exchange Select Antacid Tropical Fruit is calcium carbonate. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Army And Air Force Exchange Service

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.


Exchange Select Antacid Tropical 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 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)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • 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: Army And Air Force Exchange Service
Labeler Code: 55301
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: 03-06-2019 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.

Exchange Select Antacid Tropical Fruit Product Label Images

Exchange Select Antacid Tropical 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 (Per Tablet)

Calcium Carbonate USP 750mg

Purpose

Antacid

Uses

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

Ask A Doctor Or Pharmacist Before Use If You Are

Presently taking a prescription drug. Antacids may interact with certain prescription drug.

When Using This Product

  • •do not take more than 10 tablets in 24 hours •if pregnant do not take more than 6 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 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 tablet contains: elemental calcium 300mg •Store at room temperature. Keep the container tightly closed.

Inactive Ingredients

Adipic acid, D&C Yellow No. 10, dextrose unspecified, FD&C Red No. 40, FD &C Yellow No. 6, flavors, magnesium stearate, maltodextrin, starch, sucralose.

* Please review the disclaimer below.

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