Children's Allergy Drug Facts

Dosage Form: liquid
Publix Super Markets, Inc. Children's Allergy Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Cetirizine HCl 5 mg

Purpose

Antihistamine

Uses

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

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 breast-feeding:

• 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 or contact a Poison Control Center right away.

Directions

• 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	1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 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

• do not use if carton is opened, or if printed neckband is broken or missing


• store between 20° to 25°C (68° to 77°F)

Inactive ingredients

acetic acid, artificial grape flavor, glycerin, methylparaben, natural banana flavor, propylene glycol, propylparaben, sodium acetate, sucrose, water

Principal Display Panel

Indoor & Outdoor Allergies

Children's Allergy

Cetirizine Hydrochloride Oral Solution, 1 mg/mL

Antihistamine

24 Hour Relief of:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat or Nose

Grape Flavored Syrup

2 yrs. and older

Dosing Cup Included

Original Prescription Strength

Compare to active ingredient in Children's Zyrtec®

Children's Allergy Carton

CHILDRENS ALLERGY  cetirizine hydrochloride  liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 56062-974 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 5 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color YELLOW (Pale Yellow) Score      Shape Size Flavor GRAPE Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 56062-974-26 1 BOTTLE In 1 CARTON contains a BOTTLE 1 120 mL In 1 BOTTLE This package is contained within the CARTON (56062-974-26)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090254	01/15/2009

Labeler - Publix Super Markets Inc (006922009)

Revised: 05/2009Publix Super Markets Inc

More Children's Allergy Drug Facts resources

• Children's Allergy Drug Facts Side Effects (in more detail)
• Children's Allergy Drug Facts Use in Pregnancy & Breastfeeding
• Drug Images
• Children's Allergy Drug Facts Drug Interactions
• Children's Allergy Drug Facts Support Group
• 73 Reviews for Children's Allergy Drug Facts - Add your own review/rating

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