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Drug Facts
Zyrtec Tablet, Chewable
FDA Label NDC 50580-753
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 (NDC 50580-753). 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 10 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
- may be taken with or without water
- chew or crush tablets completely before swallowing
adults and children 6 years and over
Chew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet (10 mg) 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
Other Information
- store between 20° to 25°C (68° to 77°F)
- do not use if blister unit is torn or broken
Inactive Ingredients
betadex, corn starch, lactose monohydrate, magnesium stearate, mannitol, silicified microcrystalline cellulose, sucralose
Questions?
call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)
Principal Display Panel
Original Prescription Strength NDC 50580-753-24
ZYRTEC ®
Cetirizine HCl Chewable tablets,
10 mg /antihistamine
ALLERGY
Indoor + Outdoor
Allergies
Chewables
DYE-Free
24 HOUR
Relief of
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
Actual
Size
No Water
Needed
Chew or crush tablets completely
before swallowing
24 Chewable Tablets
10 mg each
Zyrtec-01 (Zyrtec 01)
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