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SPL UNCLASSIFIED SECTION

Cetirizine Hydrochloride Tablets USP 10 mg (ALLERGY RELIEF)

 Drug Facts


Active ingredient (in each tablet)

Cetirizine hydrochloride USP 10 mg


Purpose

Antihistamine


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

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.


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.


OTC - ASK DOCTOR/PHARMACIST SECTION

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


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]


Directions

adults and children6 years and overone 10 mg tablet once daily;do not take more than one 10 mgtablet in 24 hours. A 5 mgproduct may be appropriate forless severe symptoms.
adults 65 years and overask a doctor
children under 6 years of ageask a doctor
consumers with liver orkidney diseaseask a doctor

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


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


HOW SUPPLIED

Product: 50090-6168

NDC: 50090-6168-1 30 TABLET in a BOTTLE

NDC: 50090-6168-3 90 TABLET in a BOTTLE


CETIRIZINE HYDROCHLORIDE