Childrens allergy relief solution

Active ingredient (in each 5 ml)

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. (1-800-222-1222)

Directions

  • 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

  • store between 20 to 25C (68 to 77F)
  • do not use if carton is opened, or if printed neckband is broken or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions or comments?

1-800-719-9260

Ingredients and appearance - Product information

Childrens allergy relief solution- Cetirizine hcl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 11822-0475
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Cetirizine hydrochloride ( UNII: 64O047KTOA)( Cetirizine - UNII: YO7261ME24 ) 5 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Sodium benzoate ( UNII: OJ245FE5EU)
Sorbitol ( UNII: 506T60A25R)
Sucralose ( UNII: 96K6UQ3ZD4)

Product Characteristics

Flavor GRAPE

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA204226 USA

Labeler - Rite Aid Corporation( 014578892)

Package/label principal display panel

Compare to the active ingredient of Childrens Zyrtec®

childrens allergy relief

cetirizine hydrochloride oral solution 1 mg/mL

antihistamine

INDOOR & OUTDOOR ALLERGIES

DYE - FREE

SUGAR FREE

grape flavored syrup

sneezing

runny nose

itchy, watery eyes

itchy throat or nose

2 years & older

dosing cup included

4 FL OZ (118 mL)