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Drug Facts
Childrens Zyrtec Allergy Syrup
FDA Label NDC 50580-721
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 Childrens Zyrtec Allergy (NDC 50580-721). 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 5 ml), purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 5 Ml)
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.
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
- use only with enclosed dosing cup
- find right dose on chart below
- mL = milliliter
| adults and children 6 years and over | 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. |
| adults 65 years and over | 5 mL once daily; do not take more than 5 mL in 24 hours. |
| children 2 to under 6 years of age | 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 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)
- do not use if carton is opened or if carton tape or bottle wrap imprinted "SAFETY SEAL®" is broken or missing
- see bottom panel for lot number and expiration date
Inactive Ingredients
anhydrous citric acid, flavors, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose
Questions?
call 1-800-343-7805 (toll-free) or 215-273-8755 (collect).
Principal Display Panel
NDC 50580-721-05
Children's
ZYRTEC®
ALLERGY
Cetirizine HCl
1 mg /ml oral solution
antihistamine
Indoor & Outdoor Allergies
24
hour
Relief of
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
2 yrs.
& older
Bubble Gum
Syrup
Dye-Free • Sugar-Free
4 fl oz (118 ml)
Dosing Cup Included
Principal Display Panel (Zyrtec Allergy 01)
* Please review the disclaimer below.
