Cetirizine Hydrochloride

Amneal Pharmaceuticals
Amneal Pharmaceuticals

Cetirizine Hydrochloride Oral Solution Antihistamine/ Allergy 1 mg/mL

FULL PRESCRIBING INFORMATION

*Compared to Children’s Zyrtec^® active ingredient

Drug Facts

Cetirizine HCl 5 mg

Antihistamine

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose and throat

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

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 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 2 to under 6 years of age	½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.
  children under 2 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