FDA Label for Cetirizine Hydrochloride

View Indications, Usage & Precautions

OTHER
ACTIVE INGREDIENT (IN EACH 5 ML TEASPOONFUL)
PURPOSE
USES
WARNINGS
OTC - ASK DOCTOR
OTC - ASK DOCTOR/PHARMACIST
OTC - WHEN USING
OTC - STOP USE
OTC - PREGNANCY OR BREAST FEEDING
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
PRINCIPAL DISPLAY PANEL: 4 FL. OZ. (120 ML) - NDC 57237-358-12
PRINCIPAL DISPLAY PANEL: 8 FL. OZ. (240 ML) - NDC 57237-358-24

Cetirizine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Rising Pharma Holdings, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other

Drug Facts

Active Ingredient (In Each 5 Ml Teaspoonful)

Cetirizine hydrochloride, USP 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

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 toll-free number 1-800-222-1222.

Directions

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

Other Information

Store between 20 to 25°C (68 to 77°F) or store refrigerated, 2 to 8°C (36 to 46°F)

Inactive Ingredients

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

Questions Or Comments?

call toll-free 1-844-474-7464

Principal Display Panel: 4 Fl. Oz. (120 Ml) - Ndc 57237-358-12

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

cetirizine-hcl-os-hives-120mL-1 - cetirizine hcl os hives 120mL 1

Principal Display Panel: 8 Fl. Oz. (240 Ml) - Ndc 57237-358-24

NDC 57237-358-24 6 yrs. & older