Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy

Manufacturer
ST. MARY'S MEDICAL PARK PHARMACY
Effective date
2025-12-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:20:29

Key Label Information

Active Ingredients And Purpose

ACTIVE INGREDIENTS

Active Ingredients (in each tablet) Purpose Cetirizine HCl USP 10 mg................................................................Antihistimine

PURPOSE

Antihistamine

Uses

USES

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies runny nose sneezing itchy, watery eyes itching of the nose or throat

Warnings

WARNINGS

Do Not Use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

IF PREGNANT OR BREAST FEEDING:

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

Directions And Dosage

DIRECTIONS

Adults and children 6 years and over one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. Adults 65 years and over Ask a doctor Children under 6 years of age Ask a doctor Consumers with liver or kidney disease Ask a doctor

Other Label Information

INACTIVE INGREDIENTS

Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

QUESTIONS?

Call 1-844-874-7464

PRINCIPAL DISPLAY PANEL-100'S COUNT

Products

NDC Codes

Ingredients

Complete SPL Sections

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each tablet) Purpose Cetirizine HCl USP 10 mg................................................................Antihistimine

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

USES

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies runny nose sneezing itchy, watery eyes itching of the nose or throat

WARNINGS

WARNINGS SECTION

Do Not Use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

ASK DOCTOR

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

ASK DOCTOR/PHARMACIST

OTC - ASK DOCTOR/PHARMACIST SECTION

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

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

drowsines may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinary.

STOP USE

OTC - STOP USE SECTION

Stop use and ask a doctor if an allergic reaction tothis product occurs. Seek medical help right away.

IF PREGNANT OR BREAST FEEDING:

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years and over one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. Adults 65 years and over Ask a doctor Children under 6 years of age Ask a doctor Consumers with liver or kidney disease Ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

QUESTIONS?

OTC - QUESTIONS SECTION

Call 1-844-874-7464

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Manufactured by: Unique Pharmaceutical Labs. (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India Distributed by: Rising Pharma holdings, Inc. East Brunswick, NJ 08816 M. L. G/1430 Jul. 2020 126406

PRINCIPAL DISPLAY PANEL-100'S COUNT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc4536b98f-f486-7cd9-e063-6394a90a2f5d.xml2025-12-07
otcCETIRIZINE 60760-886-30.jpg2025-12-07
otcCETIRIZINE 886-30.jpg2023-01-24
otcf2f42f36-6b0a-4140-e053-2a95a90af813.xml2023-01-24