NDC 0121-4780 Cetirizine Hydrochloride

NDC Product Code 0121-4780

NDC CODE: 0121-4780

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: 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):
YELLOW (C48330 - SLIGHTLY YELLOW)
Flavor(s):
BANANA (C73364)
GRAPE (C73391)

NDC Code Structure

  • 0121 - Pharmaceutical Associates, Inc.

NDC 0121-4780-05

Package Description: 4 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Cetirizine Hydrochloride with NDC 0121-4780 is a product labeled by Pharmaceutical Associates, Inc.. The generic name of Cetirizine Hydrochloride is . The product's dosage form is and is administered via form.

Labeler Name: Pharmaceutical Associates, Inc.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Pharmaceutical Associates, Inc.
Labeler Code: 0121
Start Marketing Date: 09-15-2009 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: 12-31-2017 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

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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]

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Cetirizine Hydrochloride Product Label Images

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 5 Ml Teaspoonful)

Cetirizine hydrochloride 5 mg

Purpose

Antihistamine

Uses

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, watery eyesitching of the nose or throat

Otc - Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Otc - Ask Doctor

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

Otc - When Using

  • When 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

Otc - Stop Use

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Otc - Pregnancy Or Breast Feeding

  • If pregnant or breast-feeding if pregnant: ask a health professional before useif breast-feeding: not recommended

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.

Directions

  • Adults and children 6 years and over: 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours adults 65 years and over: 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours children 2 to under 6 years of age: 1⁄2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1⁄2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. children under 2 years of age: ask a doctor consumers with liver or kidney disease: ask a doctor

Other Information

  • Store between 20° to 25°C (68° to 77°F) colorless to slightly yellow, banana-grape flavored liquid supplied in the following oral dosage form: NDC 0121-4780-05 (unit dose cups of 5 mL)

Inactive Ingredients

Flavors, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, sodium acetate, sugar, and purified water.

Other

R07/09Manufactured by:Cypress Pharmaceutical, Inc.Madison, MS 39110Packaged by:PharmaceuticalAssociates, Inc.Greenville, SC 29605www.paipharma.com

* Please review the disclaimer below.