SPL v1
SPL
SPL Set ID c7d1829b-2cf3-aeed-e053-2a95a90ae11a
Route
ORAL
Published
Effective Date 2021-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Hypromellose 2910 (5 Mpa.s) Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol 400 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: X;36 Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2015-08-05
Description

Cetirizine Hydrochloride Tablets USP 10 mg (ALLERGY RELIEF)   Drug Facts

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Cetirizine Hydrochloride Tablets USP 10 mg (ALLERGY RELIEF)   Drug Facts

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

Cetirizine Hydrochloride Tablets USP 10 mg (ALLERGY RELIEF)

 

Drug Facts

Section 50568-5

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

Section 50569-3

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

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.

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 1-800-206-7821



 

Manufactured for: Northstar Rx LLC

                           Memphis, TN 38141

Manufactured by: Aurobindo Pharma Limited

                           Hyderabad-500 090, India

Code: TS/DRUGS/19/1993

Issued: 03/2018

Other Information
  • store between 20° to 25°C (68° to 77°F)
  • TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

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
Stop Use and Ask A Doctor If

an allergic reaction to this product occurs. Seek medical help right away.

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 a Poison Control Center right away. [1-800-222-1222]

Active Ingredient (in Each Tablet)

Cetirizine hydrochloride USP 10 mg

Package Label Principal Display Panel

Structured Label Content

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)

Cetirizine Hydrochloride Tablets USP 10 mg (ALLERGY RELIEF)

 

Drug Facts

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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

Purpose

Antihistamine

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.

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 1-800-206-7821



 

Manufactured for: Northstar Rx LLC

                           Memphis, TN 38141

Manufactured by: Aurobindo Pharma Limited

                           Hyderabad-500 090, India

Code: TS/DRUGS/19/1993

Issued: 03/2018

Other Information (Other information)
  • store between 20° to 25°C (68° to 77°F)
  • TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

When Using This Product (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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

an allergic reaction to this product occurs. Seek medical help 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.
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. [1-800-222-1222]

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Cetirizine hydrochloride USP 10 mg

Package Label Principal Display Panel (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:38.848580 · Updated: 2026-03-14T22:59:43.649746