NDC 47335-343 Cetirizine Hydrochloride

Cetirizine Hydrochloride

NDC Product Code 47335-343

NDC CODE: 47335-343

Proprietary Name: Cetirizine Hydrochloride 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 Hydrochloride 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

Color(s):
PURPLE (C48327)
Shape: ROUND (C48348)
Size(s):
8 MM
Imprint(s):
343
Score: 1
Flavor(s):
TUTTI FRUTTI (C73420)

NDC Code Structure

NDC 47335-343-15

Package Description: 30 TABLET, CHEWABLE in 1 BOTTLE

NDC 47335-343-16

Package Description: 100 TABLET, CHEWABLE in 1 BOTTLE

NDC 47335-343-83

Package Description: 30 TABLET, CHEWABLE in 1 BOTTLE

NDC 47335-343-88

Package Description: 100 TABLET, CHEWABLE in 1 BOTTLE

NDC Product Information

Cetirizine Hydrochloride with NDC 47335-343 is a a human over the counter drug product labeled by Sun Pharmaceutical Industries, Inc.. The generic name of Cetirizine Hydrochloride is cetirizine hydrochloride. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Sun Pharmaceutical Industries, 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.

Cetirizine Hydrochloride 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 5 mg/1
  • CETIRIZINE HYDROCHLORIDE 5 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.

  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SUCROSE (UNII: C151H8M554)
  • CROSPOVIDONE (UNII: 68401960MK)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GUAR GUM (UNII: E89I1637KE)
  • MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MANNITOL (UNII: 3OWL53L36A)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • TALC (UNII: 7SEV7J4R1U)

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: Sun Pharmaceutical Industries, Inc.
Labeler Code: 47335
FDA Application Number: ANDA090142 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: 09-09-2011 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.

Information for Patients

Cetirizine

Cetirizine is pronounced as (se ti' ra zeen)

Why is cetirizine medication prescribed?
Cetirizine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and allergy to other substances (such as dus...
[Read More]

* Please review the disclaimer below.

Cetirizine Hydrochloride 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 (In Each Chewable Tablet)

For 5 mg:Cetirizine hydrochloride 5 mg  For 10 mg:Cetirizine hydrochloride 10 mg

Purpose

Antihistamine

Uses

Relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Warnings

  • Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:trouble swallowingdizziness or loss of consciousnessswelling of tongueswelling in or around mouthtrouble speakingdroolingwheezing or problems breathingThese symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.  Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do Not Use

  • To prevent hives from any known cause such as:foodsinsect stingsmedicineslatex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.If you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask A Doctor Before Use If You Have

  • Liver or kidney disease. Your doctor should determine if you need a different dose.hives that are an unusual color, look bruised or blisteredhives that do not itch

Ask A Doctor Or Pharmacist Before Use If

You are taking tranquilizers or sedatives.

When Using This Product

  • Drowsiness may occur  avoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machinery

Stop Use And Ask Doctor If

  • An allergic reaction to this product occurs. Seek medical help right away.symptoms do not improve after 3 days of treatmentthe hives have lasted more than 6 weeks

If Pregnant Or Breast-Feeding:

  • If breast-feeding: not recommendedif pregnant: ask a health professional before use.

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

  • May be taken with or without waterFor 5 mg:adults and children 6 years and over1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.adults 65 years and over  1 tablet once a day; do not take more than 1 tablet in 24 hourschildren under 6 years of ageask a doctorconsumers with liver or kidney diseaseask a doctorFor 10 mg:adults and children 6 years and overone 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.adults 65 years and overask a doctorchildren under 6 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor

Other Information

  • Store between 20° to 25°C (68° to 77°F) do not use if inner safety seal is open or torn see top layer for lot number and expiration date

Inactive Ingredients

Acesulfame potassium, colloidal silicon dioxide, compressible sugar, crospovidone, FD & C Blue No # 2 Aluminum Lake, FD & C Red No # 40 Aluminum Lake, guar gum, magnesium oxide light powder, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, prosweet N & A flavor powder, talc, tutti frutti flavor

Questions?

Call toll free 1-800-818-4555 weekdays

* Please review the disclaimer below.