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DOSAGE & ADMINISTRATION SECTION.

Directions adults and children years and over: teaspoonful (5 mL) or teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than teaspoonfuls (10 mL) in 24 hours adults 65 years and over: teaspoonful (5 mL) once daily; do not take more than teaspoonful (5 mL) in 24 hours children to under years of age: 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to maximum of teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than teaspoonful (5 mL) in 24 hours. children under years of age: ask doctor consumers with liver or kidney disease: ask doctor adults and children years and over: teaspoonful (5 mL) or teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than teaspoonfuls (10 mL) in 24 hours adults 65 years and over: teaspoonful (5 mL) once daily; do not take more than teaspoonful (5 mL) in 24 hours children to under years of age: 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to maximum of teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than teaspoonful (5 mL) in 24 hours. children under years of age: ask doctor consumers with liver or kidney disease: ask doctor.

INACTIVE INGREDIENT SECTION.

Inactive ingredients. flavors, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, sodium acetate, sugar, and purified water.

INDICATIONS & USAGE SECTION.

Uses. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, watery eyesitching of the nose or throat. runny nose. sneezing. itchy, watery eyes. itching of the nose or throat.

OTC - ACTIVE INGREDIENT SECTION.

Active ingredient (in each mL teaspoonful). Cetirizine hydrochloride mg.

OTC - ASK DOCTOR SECTION.

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

OTC - ASK DOCTOR/PHARMACIST SECTION.

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

OTC - DO NOT USE 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.

Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION.

If pregnant or breast-feeding if pregnant: ask health professional before useif breast-feeding: not recommended if pregnant: ask health professional before use. if breast-feeding: not recommended.

OTC - PURPOSE SECTION.

Purpose. Antihistamine.

OTC - QUESTIONS SECTION.

Questions or comments. Call 1-800-845-8210.

OTC - STOP USE SECTION.

Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away.

OTC - WHEN USING SECTION.

When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving motor vehicle or operating machinery. drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving motor vehicle or operating machinery.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL Cup, Unit-Dose Label. Delivers mL NDC 0121-4780-05CETIRIZINE HYDROCHLORIDE SYRUP mg/5 mLFOR INSTITUTIONAL USE ONLYMfg. by: CYPRESS PHARMACEUTICAL, INC.MADISON, MS 39110pkg. by: PHARMACEUTICAL ASSOCIATES, INC.GREENVILLE, SC 29605SEE INSERTA47800500. PRINCIPAL DISPLAY PANEL Cup, Unit-Dose Label.

SPL UNCLASSIFIED SECTION.

R07/09Manufactured by:Cypress Pharmaceutical, Inc.Madison, MS 39110Packaged by: PharmaceuticalAssociates, Inc. Greenville, SC 29605www.paipharma.com.

STORAGE AND HANDLING SECTION.

Other information store between 20 to 25C (68 to 77F) colorless to slightly yellow, banana-grape flavored liquid supplied in the following oral dosage form: NDC 0121-4780-05 (unit dose cups of mL). store between 20 to 25C (68 to 77F) colorless to slightly yellow, banana-grape flavored liquid supplied in the following oral dosage form: NDC 0121-4780-05 (unit dose cups of mL).

WARNINGS SECTION.

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.. Ask doctor before use if you have liver or kidney disease. Your doctor should determine if you need different dose.. Ask 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 motor vehicle or operating machinery. drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving motor vehicle or operating machinery. Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away.. If pregnant or breast-feeding if pregnant: ask health professional before useif breast-feeding: not recommended if pregnant: ask health professional before use. if breast-feeding: not recommended Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.