Allergy Relief
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)
30 mins
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Disclaimer
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