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Drug Facts
Zyrtec Allergy Tablet, Film Coated
FDA Label NDC 50580-754
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Zyrtec Allergy (NDC 50580-754). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Cetirizine HCl 5 mg
Purpose
Antihistamine
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
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 breast-feeding: not recommended ■ if pregnant: ask a health professional before use.
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. (1-800-222-1222)
Directions
| adults and children
6 years and over | 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10mg) in 24 hours. |
| adults 65 years and over | 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours. |
| children under 6 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)
■
do not use if carton is opened. do not use if pouch is torn or damaged
■ meets USP Dissolution Test 2
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
Questions?
call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)
Principal Display Panel
NDC 50580-754-15
Zyrtec®
ALLERGY
Cetirizine HCl Tablets
5mg/antihistamine
24 Hour relief of
Sneezing
Runny Nose
Itchy Throat or Nose
Itchy, Watery Eyes
15 Tablets
5 mg each
Actual Size
Take 1 to 2 tablets* once daily depending on the severity of your symptoms
*Adults 65 and older take only one tablet per day
Indoor &
Outdoor
Allergies
5mg Strength Tablets
15
Tablets
5 mg
each
Zyrtec-1 (Zyrtec 1)
* Please review the disclaimer below.
