NDC 55910-097 Rexall Antacid Flavor Chews

Calcium Carbonate

NDC Product Code 55910-097

NDC CODE: 55910-097

Proprietary Name: Rexall Antacid Flavor Chews 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.

Product Characteristics

Color(s):
ORANGE (C48331)
PINK (C48328)
YELLOW (C48330)
Shape: ROUND (C48348)
Size(s):
14 MM
Imprint(s):
FC
Score: 1
Flavor(s):
ORANGE (C73406)
STRAWBERRY (C73417)
LEMON (C73396)

NDC Code Structure

  • 55910 - Dolgencorp, Llc

NDC 55910-097-45

Package Description: 45 TABLET, CHEWABLE in 1 BOTTLE

NDC Product Information

Rexall Antacid Flavor Chews with NDC 55910-097 is a a human over the counter drug product labeled by Dolgencorp, Llc. The generic name of Rexall Antacid Flavor Chews is calcium carbonate. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Dolgencorp, 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.

Rexall Antacid Flavor Chews 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.

  • SUCROSE (UNII: C151H8M554)

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: Dolgencorp, Llc
Labeler Code: 55910
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: 10-03-2019 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

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]


is

...
[Read More]

* Please review the disclaimer below.

Rexall Antacid Flavor Chews 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

Otc - Active Ingredient

Active ingredient (in each chewable tablet)Calcium Carbonate 750 mg

Otc - Purpose

PurposeAntacid

Indications & Usage

  • Uses Relieves
  • HeartburnSour stomachAcid indigestionUpset stomach due to these symptoms

Warnings

WarningsDo not use if you have ever had an allergic reaction to this product or any of its ingredients

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs.

Otc - When Using

Do not take more than 5 chewable tablets in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.When using this product constipation may occur

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

Directions - Adults and children 12 years and older chew and swallow 1 to 2 chewable tablets every 2-4 hours as needed. Do not exceed 5 chewable tablets in 24 hours. Children under 12 years consult a doctor.

Other Safety Information

  • Other informationEach chewable tablet contains: calcium 300mg
  • Contains soyContains FD&C yellow No. 5 (tartrazine) as a color additiveStore between 20° to 25°C (68° to 77°F) in a dry place

Inactive Ingredient

Inactive ingredients: Beeswax, carmine, carnauba wax, citric acid, corn starch, corn syrup, DL-alpha tocopherol, ethyl acetate, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 lake (tartrazine), FD&C yellow no. 6, FD&C yellow no. 6 aluminum lake, gum arabic, hydrogenated coconut oil, maltodextrin, medium chain triglycerides, methyl paraben, modified corn starch, natural and artificial flavors, phosphoric acid, pregelatinized corn starch, propyl paraben, propylene glycol, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, soybean oil, sucrose and titanium dioxide.

Otc - Questions

Questions? Call
1-800-245-2898.

* Please review the disclaimer below.