ZYRTEC HIVES- cetirizine hydrochloride solution

ZYRTEC HIVES by

Drug Labeling and Warnings

ZYRTEC HIVES by is a Otc medication manufactured, distributed, or labeled by Kenvue Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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.

Warnings

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.

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

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

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

If pregnant or breast-feeding:
■ if breast-feeding: not recommended
■ if pregnant: ask a health professional before use.

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

INGREDIENTS AND APPEARANCE

ZYRTEC HIVES 
cetirizine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-128
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (COLORLESS)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-128-04	1 in 1 CARTON	04/02/2025
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022155	04/02/2025

Labeler - Kenvue Brands LLC (118772437)