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SPL UNCLASSIFIED SECTION

Cetirizine HCl Capsules 10 mg (Hives Relief)Drug Facts


Active ingredient (in each capsule)

Cetirizine HCI USP 10 mg


Purpose

Antihistamine


Uses

relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occuring.


Warnings

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

  • trouble swallowing
  • dizziness or loss of consciousness
  • swelling of tongue
  • swelling in or around mouth
  • trouble speaking
  • drooling
  • wheezing or problems breathing

Do not use

because this product will not stop hives from occuring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

  • to prevent hives from any known cause such as: foods insect stingsmedicineslatex or rubber gloves

Ask a doctor before use if you have

  • liver or kidney disease. Your doctor should determine if you need a different dose.
  • hives that are an unusual color, look bruised or blistered
  • hives that do not itch

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.
  • symptoms do not improve after 3 days of treatment.
  • the hives have lasted more than 6 weeks.

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 capsule once daily;do not take more than one 10 mgcapsule 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° - 25°C (68° - 77°F)
  •  avoid high humidity and excessive heat above 40°C (104°F)
  •  protect from light
  •  do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing.

Inactive ingredients

black iron oxide, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution