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FDA Drug information

Allergy Relief

Read time: 1 mins
Marketing start date: 29 Apr 2024

Summary of product characteristics


Dosage And Administration

Directions adults and children 6 years and over Take one 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 over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Indications And Usage

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

Warnings

Warnings 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. Ask 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 tranquilizers or sedatives. When using this product drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks 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. If pregnant or breast-feeding: if breast-feeding: not recommended if 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 (1-800-222-1222) right away.

Effective Time

20230630

Version

100

Active Ingredient

Active ingredient (in each tablet) Cetirizine HCl 10 mg

Dosage And Administration Table

adults and children 6 years and over Take one 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 over ask a doctor
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor

Inactive Ingredient

Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Purpose

Purpose Antihistamine

Spl Product Data Elements

Allergy Relief Cetirizine HCl LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE MICROCRYSTALLINE CELLULOSE CETIRIZINE HYDROCHLORIDE CETIRIZINE G;4

Application Number

ANDA209274

Brand Name

Allergy Relief

Generic Name

Cetirizine HCl

Product Ndc

71335-9733

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

Cetirizine Hydrochloride 10 mg Tablet Label

Spl Unclassified Section

Principal Display Panel *Compare to the active ingredient in Zyrtec ® Allergy Relief Cetirizine HCl Tablets USP, 10 mg/Antihistamine Indoor & Outdoor Allergies 24 hour relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Original Prescription Strength Tablets *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Zyrtec®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by: Camber Consumer Care Inc, Piscataway, NJ 08854, USA

Ask Doctor

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

Ask Doctor Or Pharmacist

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

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.

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 (1-800-222-1222) right away.

Questions

Questions or comments? Call 1-888-588-1418 Monday-Friday 9AM-5PM EST

Stop Use

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

When Using

When using this product drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery

Pregnancy Or Breast Feeding

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

How Supplied

HOW SUPPLIED NDC: 71335-9733-1: 30 Tablets in a BOTTLE, PLASTIC NDC: 71335-9733-2: 14 Tablets in a BOTTLE, PLASTIC NDC: 71335-9733-3: 7 Tablets in a BOTTLE, PLASTIC NDC: 71335-9733-4: 10 Tablets in a BOTTLE, PLASTIC NDC: 71335-9733-5: 15 Tablets in a BOTTLE, PLASTIC NDC: 71335-9733-6: 90 Tablets in a BOTTLE, PLASTIC NDC: 71335-9733-7: 20 Tablets in a BOTTLE, PLASTIC NDC: 71335-9733-8: 60 Tablets in a BOTTLE, PLASTIC NDC: 71335-9733-9: 100 Tablets in a BOTTLE, PLASTIC

Storage And Handling

Other Information store between 20º to 25ºC (68º to 77ºF) contains no ingredient made from a gluten-containing grain(wheat, barley or rye)

Learning Zones

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Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.