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Drug Facts
Zyrtec Allergy Capsule, Liquid Filled
FDA Label NDC 50580-786
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 50580-786). 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 capsule), 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 Capsule)
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.
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.
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 | one 10 mg capsule once daily; do not take more than one 10 mg capsule 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 at 20°-25°C (68°-77°F)
- avoid high humidity and excessive heat above 40°C (104°F)
- protect from light
- do not use if clamshell is opened or if foil inner seal imprinted with “Sealed For Your Safety” is broken or missing
Inactive Ingredients
gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol
Questions?
call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)
Principal Display Panel
Original Prescription Strength
NDC 50580-786-12
ZYRTEC
®
ALLERGY
INDOOR + OUTDOOR
ALLERGIES
Cetirizine HCl/
antihistamine
10 mg capsules
LIQUID
GELS
24
HOUR
RELIEF OF
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
(Actual Size)
12
LIQUID GELS*
*LIQUID-FILLED CAPSULES
10 mg each
Zyrtec-1 (Zyrtec 1)
* Please review the disclaimer below.
