NDC 69676-0019 Tummy Relief

Calcium Carbonate

NDC Product Code 69676-0019

NDC CODE: 69676-0019

Proprietary Name: Tummy Relief 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):
WHITE (C48325 - TAN)
Shape: ROUND (C48348)
Size(s):
13 MM
Imprint(s):
G;STRAWBERRY
Score: 1
Flavor(s):
BERRY (C73365)
VANILLA (C73421)

NDC Code Structure

  • 69676 - Genexa Inc.

NDC 69676-0019-7

Package Description: 30 TABLET, CHEWABLE in 1 BOTTLE

NDC Product Information

Tummy Relief with NDC 69676-0019 is a a human over the counter drug product labeled by Genexa Inc.. The generic name of Tummy Relief is calcium carbonate. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Genexa Inc.

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.

Tummy Relief 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 400 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.

  • BEET (UNII: N487KM8COK)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • DEXTROSE (UNII: IY9XDZ35W2)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • RICE BRAN (UNII: R60QEP13IC)

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: Genexa Inc.
Labeler Code: 69676
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: 10-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 11-30-2021 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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.

Tummy Relief 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

Other

Drug Facts

  • Other informationeach tablet contains: elemental calcium 160mg
  • Store between 20-25°C (68-77°F) in a dry place out of direct sunlight

All ingredients are USDA Certified Organic, except Calcium Carbonate. Calcium Carbonate is a mineral and USDA regulations do not certify minerals. Genexa's Calcium Carbonate is Non-GMO Project Verified.

Distributed by:Genexa Inc.Beverly Hills, CA 90211www.genexa.comBOTTLE IS SAFETY SEALED. DO NOT USE IF BOTTLE SEAL IS DISTURBED OR MISSING.

GENEXA®Questions? Comments?1-855-GENEXA-1hello@genexa.com

Otc - Active Ingredient

Active ingredient (in each tablet)Calcium Carbonate USP 400mg

Otc - Purpose

PurposeAntacid

Indications & Usage

  • Uses relieves
  • Heartburnacid indigestionsour stomachupset stomach associated with these symptoms

Warnings

Warnings

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if your child is presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Otc - When Using

  • When using this productdo not give the child more than 3 tablets (ages 2-5) or 6 tablets (ages 6-11) in 24 hoursdo not give the child the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

DirectionsFind right dose on chart below based on weight (preferable); otherwise use ageWeight (lbs)Age (years)Doseover 486-11chew 2 tablets as symptoms occur, not to exceed 6 tablets in 24 hours24-472-5chew 1 tablet as symptoms occur, not to exceed 3 tablets in 24 hoursunder 24under 2ask a doctor

Inactive Ingredient

Inactive ingredients organic beet root, organic carnauba wax, organic flavors, organic dextrose, organic maltodextrin, organic rice bran extract

* Please review the disclaimer below.