CHILDRENS CETIRIZINE HYDROCHLORIDE

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

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 or throat

Warnings

WARNINGS SECTION

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 - 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 a doctor if an allergic reaction to this product occurs. Seek medical help right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding:

• if breast-feeding: not recommended
• if pregnant: ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or 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	5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
adults 65 years and over	5 mL once daily; do not take more than 5 mL in 24 hours.
children 2 to under 6 years of age	2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 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

STORAGE AND HANDLING SECTION

• each 5 mL contains: sodium 4 mg
• do not use if carton is opened or if imprinted safety seal is broken or missing
• see bottom panel for lot number and expiration date
• store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

bubble gum artificial flavor, glacial acetic acid, glycerin, propylene glycol, purified water, sodium acetate anhydrous, sodium benzoate, sucralose

Questions?

OTC - QUESTIONS SECTION

call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the
active ingredient
in Children's Zyrtec^®*

NDC 51672-2148-8

Children's
Cetirizine
Hydrochloride
Oral Solution
1 mg/mL
ALLERGY
Antihistamine
Indoor & Outdoor Allergies

SUGAR FREE

24
Hour
Relief of:

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

2 Yrs. & older

Bubble Gum
Flavor

Dosing Cup Included

4 FL OZ
(120 mL)

DailyMed RxNorm Mappings#

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FDA-Initiated Inactive NDC Indexing#

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DailyMed Dashboard NDC Coverage#

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

• CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE BUBBLE GUM
• Cetirizine Hydrochloride
• Cetirizine
• acetic acid
• glycerin
• propylene glycol
• sodium acetate anhydrous
• sodium benzoate
• sucralose
• water

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

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Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Observed Orange Book product history#

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Product history page 1 of 3 · 86 observed states.

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Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.