Cetirizine Hydrochloride Solution
FDA Label NDC 57237-358

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Cetirizine Hydrochloride (NDC 57237-358). 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 teaspoonful), purpose, uses, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ 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

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