NDC 0536-1007 Rugby Cal-gest Antacid Assorted Flavors
Antacid Tablets Tablet, Chewable Oral

Product Information

Rugby Cal-gest Antacid Assorted Flavors is a human over the counter drug product labeled by Rugby Laboratories, Inc.. The generic name of Rugby Cal-gest Antacid Assorted Flavors is antacid tablets. The product's dosage form is tablet, chewable and is administered via oral form.

Product Code0536-1007
Proprietary Name 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.
Rugby Cal-gest Antacid Assorted Flavors
Non-Proprietary Name 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.
Antacid Tablets
Product Type 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.
Human Otc Drug
Dosage FormTablet, 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.
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.
Rugby Laboratories, Inc.
Labeler Code0536
FDA Application Number 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.
part331
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
10-30-2019
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Rugby Cal-gest Antacid Assorted Flavors?


Product Characteristics

Color(s)WHITE (C48325)
ShapeROUND (C48348)
Size(s)16 MM
Imprint(s)RP101
Score1
Flavor(s)FRUIT (C73389)

Product Packages

NDC 0536-1007-15

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

Price per Unit: $0.01379 per EA

Product Details

What are Rugby Cal-gest Antacid Assorted Flavors Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • CALCIUM CARBONATE 500 mg/1 - Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.

Rugby Cal-gest Antacid Assorted Flavors Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 308907 - calcium carbonate 500 MG (Ca 200 MG) Chewable Tablet
  • RxCUI: 308907 - calcium carbonate 500 MG Chewable Tablet
  • RxCUI: 308907 - calcium carbonate 500 MG (equivalent to calcium 200 MG) Chewable Tablet
  • RxCUI: 998704 - Cal-Gest 500 MG (Ca 200 MG) Chewable Tablet
  • RxCUI: 998704 - calcium carbonate 500 MG Chewable Tablet [Cal Gest]

Rugby Cal-gest Antacid Assorted Flavors Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Patient Education



is


...
[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.

Rugby Cal-gest Antacid Assorted Flavors Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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

• do not use the maximum dosage for more than 2 weeks.


Directions



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


Other Information



• Store below 30°C (86°F).

• Keep the container tightly closed

• For calcium and magnesium content see Supplement Facts.


Inactive Ingredients



adipic acid, blue 1 lake, dextrose, flavors, magnesium stearate, maltodextrin, red 27 lake, starch, sucralose, yellow 6 lake, yellow 10 lake.

CALCIUM SUPPLEMENT

USES: As a daily source of extra calcium.

DIRECTIONS: Chew 2 tablets once or twice daily with a meal

Supplement Facts

Serving Size: 2 Tablets

Servings Per Container: 75

Amount Per Serving %Daily Value
Calories 5
Sugars 1.5g
Calcium 400mg40%
Magnesium 2mg less than 1%

Package/Label Principal Display Panel



Compare to active ingredient in Tums*

Rugby

Cal-Gest Antacid

Assorted Flavors

Rich Calcium Source

150 Chewable Tablets

Safety sealed: Do not use if printed seal under cap is torn or missing



* Please review the disclaimer below.