Cetirizine Hydrochloride

Amneal Pharmaceuticals
Amneal Pharmaceuticals

Cetirizine Hydrochloride Oral Solution Antihistamine/ Hives Relief 1 mg/mL

FULL PRESCRIBING INFORMATION

*Compared to Children’s Zyrtec^® active ingredient

Drug Facts

Cetirizine HCl 5 mg

Antihistamine

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

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

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

The 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 injection 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.

Do not use

• to prevent hives from any known cause such as:
  ■ foods ■ insect stings ■ medicines ■ latex or rubber gloves
  because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way of preventing 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
• if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

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

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 breastfeeding:

• 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 of contact a Poison Control Center right away. (1-800-222-1222)

• use only with enclosed dosing cup

  adults and children 6 years and over	1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
  adults 65 years and over	1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
  children under 6 years of age	ask a doctor
  consumers with liver or kidney disease	ask a doctor

• store between 20° to 25°C (68° to 77°F)
• TAMPER EVIDENT: DO NOT USE IF NECKBAND IMPRINTED “SEALED FOR YOUR PROTECTION” IS BROKEN OR MISSSING.
• See end panel for lot number and expiration date.

Sucrose, Glycerin, Propylene Glycol, Methylparaben, Propylparaben, Sodium Acetate, Glacial Acetic Acid, Artificial Grape Flavor, Purified Water.

Call 1-877-835-5472

Monday through Friday 9AM – 5 PM EST.

*This product is not manufactured or distributed by McNeil-PPC, Inc., distributor of Zyrtec^® is a registered trademark of UCB Pharma, S.A.

Distributed by: Amneal Pharmaceuticals

Glasgow, KY 42141

Rev. 09-2009