Cetirizine 10 Mg

SPL v3

SPL

SPL Set ID afd7b4c9-9ef0-52e8-e053-2a95a90a6b33

Route

ORAL

Published

Effective Date 2020-09-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (10 mg)

Inactive Ingredients

Hypromelloses Lactose Magnesium Stearate Starch, Corn Polyethylene Glycol Povidone Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: CTN;10 Shape: bullet Color: white Size: 8 mm Score: 1

Marketing Status

ANDA Active Since 2020-09-21

Description

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

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

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

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

120005

Stop Use

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

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.

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 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

Questions?

Call 1-866-562-4597

Other Information

store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature]

Active Ingredients

Active Ingredients (in each tablet) Purpose

Cetirizine HCl USP 10 mg................................................................Antihistimine

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.

Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding:

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

Principal Display Panel 100's Count

———PRINCIPAL DISPLAY PANEL———

Rising® 16571-402-10

Original Prescription Strength

Cetirizine Hydrochloride Tablets USP 10 mg

6 yrs & older

100 Tablets

Principal Display Panel 500's Count

———PRINCIPAL DISPLAY PANEL———

Rising® 16571-402-50

Original Prescription Strength

Cetirizine Hydrochloride Tablets USP 10 mg

6 yrs & older

500 Tablets

Package Label.principal Display Panel

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

120005

Purpose (PURPOSE)

Antihistamine

Stop Use (STOP USE)

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

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.

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 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

Questions? (QUESTIONS?)

Call 1-866-562-4597

Other Information (OTHER INFORMATION)

store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature]

Active Ingredients (ACTIVE INGREDIENTS)

Active Ingredients (in each tablet) Purpose

Cetirizine HCl USP 10 mg................................................................Antihistimine

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.

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.

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

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

Principal Display Panel 100's Count (PRINCIPAL DISPLAY PANEL-100'S COUNT)

———PRINCIPAL DISPLAY PANEL———

Rising® 16571-402-10

Original Prescription Strength

Cetirizine Hydrochloride Tablets USP 10 mg

6 yrs & older

100 Tablets

Principal Display Panel 500's Count (PRINCIPAL DISPLAY PANEL-500'S COUNT)

———PRINCIPAL DISPLAY PANEL———

Rising® 16571-402-50

Original Prescription Strength

Cetirizine Hydrochloride Tablets USP 10 mg

6 yrs & older

500 Tablets

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

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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 120005", "PURPOSE": "Antihistamine", "STOP USE": "Stop use and ask a doctor if an allergic reaction tothis product occurs. Seek medical help right away.", "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.", "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 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", "QUESTIONS?": "Call 1-866-562-4597", "OTHER INFORMATION": "store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]", "ACTIVE INGREDIENTS": "Active Ingredients (in each tablet) Purpose Cetirizine HCl USP 10 mg................................................................Antihistimine", "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.", "KEEP OUT OF REACH OF CHILDREN": "In case of overdose, get medical help or contact Poison Control Center right away.", "IF PREGNANT OR BREAST FEEDING:": "if breast-feeding: not recommended if pregnant: ask a health professional before use.", "PRINCIPAL DISPLAY PANEL-100'S COUNT": "———PRINCIPAL DISPLAY PANEL——— Rising® 16571-402-10 Original Prescription Strength Cetirizine Hydrochloride Tablets USP 10 mg 6 yrs & older 100 Tablets", "PRINCIPAL DISPLAY PANEL-500'S COUNT": "———PRINCIPAL DISPLAY PANEL——— Rising® 16571-402-50 Original Prescription Strength Cetirizine Hydrochloride Tablets USP 10 mg 6 yrs & older 500 Tablets"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:00.283566 · Updated: 2026-03-14T23:00:18.099176