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Drug Facts
Zyrtec Hives Solution
FDA Label NDC 50580-128
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 Hives (NDC 50580-128). 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, severe allergy warning, do not use, otc - ask doctor, otc - ask doctor/pharmacist, 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 HCI 5 mg
Purpose
Antihistamine
Uses
reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
Severe Allergy Warning
Severe Allergy Warning: Get emergency help
immediately if you have hives along with any of the
following symptoms:
■ trouble swallowing
■ dizziness or loss of consciousness
■ swelling of tongue
■ swelling in or around mouth
■ trouble speaking
■ drooling
■ wheezing or problems breathing
These symptoms may be signs of anaphylactic shock.
This condition can be life threatening if not treated by a health professional
immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.
Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for anaphylaxis or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.
Do Not Use
■ to
prevent hives from any known cause such as:
■ foods
■ insect stings
■ medicines
■ latex or rubber gloves
because this product will not stop hives from occurring. Avoiding the cause of your hives is the only
way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives,
see your doctor for a medical exam. Your doctor may be able to help you find a cause.
■ 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.
■ hives that are an unusual color, look bruised or blistered
■ hives that do not itch
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.
■ symptoms do not improve after 3 days of treatment
■ the hives have lasted more than 6 weeks
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 under 6 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Storage And Handling
Other information
■ store between 20° to 25°C (68° to 77°F)
■ do not use if carton is opened or if bottle wrap imprinted with “Sealed For Your Safety” is broken or missing
Inactive Ingredients
Inactive ingredients anhydrous citric acid, flavors, propylene glycol, purified water, sodium benzoate,
sorbitol solution, sucralose
Questions?
Questions? call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)
Principal Display Panel
NDC 50580-128-04
Children’s
ZYRTEC®HIVES
Cetirizine HCl oral solution
1 mg/ml/antihistamine
Hives Relief
6 yrs & old
HIVES RELIEF
24 Hour relief
Reduces Itching Due to Hives
Reduces Hives
Grape Flavor
4 fl oz (118ml)
Dosing cup included
* Please review the disclaimer below.
