CETIRIZINE HYDROLORIDE Allergy

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OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each 5 mL teaspoonful)

Cetirizine hydrochloride, USP 5mg

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 or 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.

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

• drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

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

If pregnant or breast-feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

• 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

In case of overdose, get medical help or contact a Poison Control Center right away toll-free number 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

Other information

OTHER SAFETY INFORMATION

Store between 20 to 25ºC (68 to 77ºF) or store refrigerated, 2 to 8ºC (36 to 46ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial grape flavor, glacial acetic acid, glycerin, methylparaben, purified water, propylene glycol, propylparaben, sodium acetate, and sucrose

Questions or comments?

SPL UNCLASSIFIED SECTION

call toll-free 1-800-818-4555 weekdays

Dosing Cup Included

Dosing cup should be washed and left to air dry after each use.

Do not use if carton is opened, or if seal on bottle is broken or missing.

Dist. by:      Caraco Pharmaceutical Laboratories, Ltd.

              Detroit, Michigan 48202

Mfg. by: SUN Pharmaceutical Industries, Inc.

              Bryan, Ohio 43506

6028L01                                          Iss: 09/11

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57664-263-31
 
2 years & older

Children’s

Cetirizine

Hydrochloride

1mg / mL  Oral Solution, USP

antihistamine

ALLERGY

Indoor and Outdoor Allergies

24 Hour Relief of

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

Dosing Cup Included

Do not use if carton is opened, or if seal on bottle is broken or missing.

2 years and older

Grape Syrup

4 fl. oz. (120 mL)                    
 

 
 

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Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

• CETIRIZINE HYDROLORIDE Allergy
• CETIRIZINE HYDROLORIDE
• CETIRIZINE HYDROCHLORIDE
• CETIRIZINE
• ACETIC ACID
• GLYCERIN
• METHYLPARABEN
• WATER
• PROPYLENE GLYCOL
• PROPYLPARABEN
• SODIUM ACETATE
• SUCROSE

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