NDC 57896-663 Gericare Regular Strength

Antacid Tablets

NDC Product Code 57896-663

NDC Code: 57896-663

Proprietary Name: Gericare Regular Strength Additional informationCallout TooltipWhat 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: Antacid Tablets Additional informationCallout TooltipWhat 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)
RED (C48326)
GREEN (C48329)
Shape: ROUND (C48348)
Size(s):
16 MM
Imprint(s):
RP101
Score: 1
Flavor(s):
FRUIT (C73389 - ASSORTED)

Code Structure
  • 57896 - Geri-care Pharmaceuticals Corp
    • 57896-663 - Gericare Regular Strength

NDC 57896-663-15

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

NDC Product Information

Gericare Regular Strength with NDC 57896-663 is a a human over the counter drug product labeled by Geri-care Pharmaceuticals Corp. The generic name of Gericare Regular Strength is antacid tablets. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Geri-care Pharmaceuticals Corp

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 Additional informationCallout TooltipWhat 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.


Gericare Regular Strength Active Ingredient(s)

Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipAbout 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 (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)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Geri-care Pharmaceuticals Corp
Labeler Code: 57896
FDA Application Number: part331 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-05-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Gericare Regular Strength Product Label Images

Gericare Regular Strength 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 500mg

Purpose

Antacid

Uses

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

Warnings

  • Ask a doctor or pharmacist before use if you are presently 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 than10 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 and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor •do not take for symptoms that persist for more than 2 weeks unless advised by a doctor.

Other Information

• each tablet contains: elemental calcium 200 mg• store at room temperature. Keep the container tightly closed

Inactive Ingredients

Adipic acid, D & C red 27 lake , D&C yellow 10 lake, dextrose, FD&C blue 1 lake ,FD & C yellow 6 lake, flavors, magnesium stearate, maltodextrin, , starch, sucralose,

* Please review the disclaimer below.

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