NDC 51824-076 Careall Cetirizine Hcl

Cetirizine

NDC Product Code 51824-076

NDC CODE: 51824-076

Proprietary Name: Careall Cetirizine Hcl 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: Cetirizine 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.

Product Characteristics

Shape: RECTANGLE (C48347)
Size(s):
9 MM
Imprint(s):
G;4

NDC Code Structure

  • 51824 - New World Imports

NDC 51824-076-01

Package Description: 30 TABLET in 1 BOTTLE

NDC Product Information

Careall Cetirizine Hcl with NDC 51824-076 is a a human over the counter drug product labeled by New World Imports. The generic name of Careall Cetirizine Hcl is cetirizine. The product's dosage form is tablet and is administered via oral form.

Labeler Name: New World Imports

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.

Careall Cetirizine Hcl 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.

  • CETIRIZINE HYDROCHLORIDE 10 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.

  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

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: New World Imports
Labeler Code: 51824
FDA Application Number: ANDA209274 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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: 03-02-2020 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: 12-31-2021 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.

Careall Cetirizine Hcl Product Label Images

Careall Cetirizine Hcl 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

Cetirizine 10mg

Otc - Purpose

Antihistamine

Otc - Keep Out Of Reach Of Children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away

Indications & Usage

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nose, sneezing, itchy, watery eys, itching of the nose or throat

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or an antihistamine containing hydroxyzineAsk a doctor before use if you have liver or kidney disease.  Your doctor should determine if you need a different dose.Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizersWhen using this product drowsiness may occur.  Avoid alcoholic drinks.  Alcohol, sedatives and tranquilizers may increase drowsiness.  Be careful when driving a motor vehicle or operating machinery.Stop use and ask a doctor if an allergic reaction to this product occurs.  Seek medical help right away.

Dosage & Administration

Adult and children over 6 years old: One 10mg tablet once daily: no more than one 10mg tablet in 24 hours.  A 5mg product may be appropriate for less severe symptomsAdults 65 years and over: ask a doctorChildren under 6 years of age: ask a doctorConsumers with liver or kidney disease: ask a doctor

Inactive Ingredient

Colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

* Please review the disclaimer below.