NDC 42961-045 Trial Antacid

Calcium Carbonate

NDC Product Code 42961-045

NDC CODE: 42961-045

Proprietary Name: Trial Antacid 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 - SNOW WHITE)
Shape: ROUND (C48348)
Size(s):
13 MM
Imprint(s):
ZEE;TL
Score: 1
Flavor(s):
SPEARMINT (C73416 - SPEARMINT)

NDC Code Structure

  • 42961 - Cintas Corporation

NDC 42961-045-04

Package Description: 500 CARTON in 1 CARTON > 50 CARTON in 1 CARTON (42961-045-03) > 125 PACKET in 1 CARTON (42961-045-02) > 2 TABLET in 1 PACKET (42961-045-01)

NDC Product Information

Trial Antacid with NDC 42961-045 is a a human over the counter drug product labeled by Cintas Corporation. The generic name of Trial Antacid is calcium carbonate. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Cintas Corporation

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Trial Antacid 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 420 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.

  • SORBITOL (UNII: 506T60A25R)
  • ACACIA (UNII: 5C5403N26O)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

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: Cintas Corporation
Labeler Code: 42961
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: 01-06-2021 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Trial Antacid Product Label Images

Trial Antacid 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 tablet)  Calcium Carbonate-420 mg

Otc - Purpose

Purpose-Antacid

Indications & Usage

Uses relieves:■ heartburn■ acid indigestion■ sour stomach■ upset stomach due to these symptoms

Dosage & Administration

  • Directionschew 2 to 4 tablets. Repeat hourly if symptoms return.do not take more than 18 tablets in 24 hoursdo not use the maximum dosage more than 2 weeks

Warnings

WarningsAsk a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interferewith certain prescription drugs

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. In case of overdose,  get medical help or contact a Poison Control Center right away.  Prompt medical attention is critical for adults as well as for  children even if you do not notice any signs or symptoms.

Inactive Ingredient

Nactive ingredientsacacia*, cornstarch*, magnesium stearate, silica*, sorbitol, mint flavor, stearic acid* *contains one or more of these ingredients

* Please review the disclaimer below.