CETIRIZINE HYDROCHLORIDE

Drug Facts

Cetirizine hydrochloride, USP 5 mg

Antihistamine

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Warnings

Label information

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.

Label information

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.

Label information

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

Label information

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

Label information

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

Label information

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

Label information

If pregnant or breast-feeding:

• if breast-feeding: not recommended
• if pregnant: ask a health professional before use.

Label information

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away toll-free number 1-800-222-1222.

• use with a dosing cup

adults and children 6 years and over	1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
adults 65 years and over	1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Store between 20 to 25ºC (68 to 77ºF) or store refrigerated, 2 to 8ºC (36 to 46ºF)

glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose

call toll-free 1-844-474-7464

NDC 57237-358-12                                6 yrs. & older

Children’s Cetirizine Hydrochloride Oral Solution, USP

1 mg/mL

Antihistamine
Grape Flavored

HIVES Relief

24 hour Relief of ITCHING
Due to Hives

4 fl. oz. (120 mL)

Dosing cup should be washed and left to air dry after each use. Do not use if seal on bottle is broken or missing.

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

Issued: 09/2025

[Image in the official label — see DailyMed source]

[Image in the official label — see DailyMed source]

[Image in the official label — see DailyMed source]

NDC 57237-358-24                        6 yrs. & older

Children’s Cetirizine Hydrochloride Oral Solution, USP

1 mg/mL

Antihistamine
Grape Flavored

HIVES Relief

24 hour Relief of ITCHING
Due to Hives

8 fl. oz. (240 mL)

Dosing cup should be washed and left to air dry after each use. Do not use if seal on bottle is broken or missing.

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

Issued: 09/2025

[Image in the official label — see DailyMed source]

[Image in the official label — see DailyMed source]

[Image in the official label — see DailyMed source]