Cetirizine Hydrochloride Tablets Usp

SPL v3

SPL

SPL Set ID 9c2b97d9-9990-46ab-9027-c34ffb07ce8f

Route

ORAL

Published

Effective Date 2018-12-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (5 mg)

Inactive Ingredients

Hypromellose, Unspecified Lactose, Unspecified Form Magnesium Stearate Starch, Corn Polyethylene Glycol, Unspecified Povidone, Unspecified Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: CTN;5 Shape: bullet Color: white Size: 7 mm Score: 1

Marketing Status

ANDA Active Since 2009-10-01

Description

Cetirizine HCl USP 5 mg

Purpose

Antihistimine

Medication Information

Purpose

Antihistimine

Description

Cetirizine HCl USP 5 mg

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

Section 42229-5

Manufactured by:

Unique Pharmaceutical Labs,

(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),

Mumbai 400 030, India.

Distributed by:

Rising Pharmaceuticals, Inc.

Saddle Brook, NJ 07663

M. L. G/1430 May 2018

120004

Repackaged By;

Proficient Rx LP

Thousand Oaks 91320

Stop Use

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

Questions

Call 1-866-562-4597

Ask Doctor

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

Directions

Adults and children 6years and over	1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours
Adults 65 years and over	1 tablet once a day; do not take more than 1 tablet in 24 hours
Children under 6 years of age	Ask a doctor
Consumers with liver or kidney disease	Ask a doctor

Do Not Use

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.

Other Information

Store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature].

Inactive Ingredients

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

Ask Doctor/pharmacist

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

When Using This Product

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

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 Poison Control Center right away. (1-800-222-1222)

Active Ingredients (in Each Tablet)

Cetirizine HCl USP 5 mg

Cetirizine Hydrochloride Tablets Usp 5 Mg

NDC 71205-093-30

Original Prescription Strength

Cetirizine Hydrochloride

Tablets 5 mg

30 Tablets

Structured Label Content

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

Section 42229-5 (42229-5)

Manufactured by:

Unique Pharmaceutical Labs,

(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),

Mumbai 400 030, India.

Distributed by:

Rising Pharmaceuticals, Inc.

Saddle Brook, NJ 07663

M. L. G/1430 May 2018

120004

Repackaged By;

Proficient Rx LP

Thousand Oaks 91320

Purpose (PURPOSE)

Antihistimine

Stop Use (STOP USE)

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

Questions (QUESTIONS)

Call 1-866-562-4597

Ask Doctor (ASK DOCTOR)

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

Directions (DIRECTIONS)

Adults and children 6years and over	1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours
Adults 65 years and over	1 tablet once a day; do not take more than 1 tablet in 24 hours
Children under 6 years of age	Ask a doctor
Consumers with liver or kidney disease	Ask a doctor

Do Not Use (DO NOT USE)

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.

Other Information (OTHER INFORMATION)

Store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature].

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Ask Doctor/pharmacist (ASK DOCTOR/PHARMACIST)

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

When Using This Product (WHEN USING THIS PRODUCT)

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

If Pregnant Or Breast Feeding (IF PREGNANT OR BREAST-FEEDING)

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

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222)

Active Ingredients (in Each Tablet) (ACTIVE INGREDIENTS (IN EACH TABLET))

Cetirizine HCl USP 5 mg

Cetirizine Hydrochloride Tablets Usp 5 Mg (Cetirizine Hydrochloride Tablets USP 5 mg)

NDC 71205-093-30

Original Prescription Strength

Cetirizine Hydrochloride

Tablets 5 mg

30 Tablets

Advanced Ingredient Data

[{"name": "Cetirizine", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE, UNSPECIFIED FORM", "unii": "J2B2A4N98G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "magnesium stearate", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "starch, corn", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "titanium dioxide", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Manufactured by: Unique Pharmaceutical Labs, (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663 M. L. G/1430 May 2018 120004 Repackaged By; Proficient Rx LP Thousand Oaks 91320", "PURPOSE": "Antihistimine", "STOP USE": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.", "QUESTIONS": "Call 1-866-562-4597", "ASK DOCTOR": "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.", "DIRECTIONS": "Adults and children 6years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours Adults 65 years and over 1 tablet once a day; do not take more than 1 tablet in 24 hours Children under 6 years of age Ask a doctor Consumers with liver or kidney disease Ask a doctor", "DO NOT USE": "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.", "OTHER INFORMATION": "Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].", "INACTIVE INGREDIENTS": "hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.", "ASK DOCTOR/PHARMACIST": "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.", "WHEN USING THIS PRODUCT": "• drowsines may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinary.", "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 Poison Control Center right away. (1-800-222-1222)", "ACTIVE INGREDIENTS (IN EACH TABLET)": "Cetirizine HCl USP 5 mg", "Cetirizine Hydrochloride Tablets USP 5 mg": "NDC 71205-093-30 Original Prescription Strength Cetirizine Hydrochloride Tablets 5 mg 30 Tablets"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:54.988820 · Updated: 2026-03-14T22:55:42.107827