Cetirizine Hydrochloride Oral Solution Antihistamine/ Allergy 1 mg/mL

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SPL UNCLASSIFIED SECTION

*Compared to Children’s Zyrtec^® active ingredient

Drug Facts

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL teaspoonful) 

Cetirizine HCl 5 mg

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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)

Directions

DOSAGE & ADMINISTRATION SECTION

• use only with enclosed dosing cup
• find right dose on chart below
• mL = milliliter

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

Other information

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• 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.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

Questions?

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Call 1-877-835-5472

Monday through Friday 9AM – 5PM EST.

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

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Distributed by: Amneal Pharmaceuticals
Glasgow, KY 42141

Rev. 03-2015-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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• Cetirizine Hydrochloride
• Cetirizine
• ACETIC ACID
• GLYCERIN
• METHYLPARABEN
• PROPYLENE GLYCOL
• PROPYLPARABEN
• SODIUM ACETATE
• SUCROSE
• WATER

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