OTC Medication Information: Safeway Children Allergy Relief

SAFEWAY CHILDREN ALLERGY RELIEF- cetirizine hydrochloride solution
Safeway Inc.

Drug Facts

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

• 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

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

Questions?

Call 1-866-923-4914

DISTRIBUTED BY BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009

PRINCIPAL DISPLAY PANEL — 240 mL Bottle Carton

NDC 21130-106-01

Signature
care

Quality Guaranteed

2 YRS. & OLDER

24 HOUR
Children’s Allergy Relief

Cetirizine Hydrochloride Oral Solution
1 mg/mL Antihistamine

BUBBLE GUM FLAVOR

Compare to
Children’s Zyrtec^®

active ingredient*

• DYE FREE
• SUGAR FREE
• Indoor & outdoor allergies
• Relief of: sneezing, runny nose, itchy & watery eyes, itchy
  throat or nose
• Dosing cup included

8 FL OZ (240 mL)

SAFEWAY CHILDREN ALLERGY RELIEF cetirizine hydrochloride solution

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-106 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 acetic acid glycerin methylparaben propylene glycol propylparaben water sodium acetate anhydrous sucralose

Product Characteristics Color YELLOW (colorless to slightly yellow) Score Shape Size Flavor BUBBLE GUM (Sugar Free) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:21130-106-01 1 BOTTLE in 1 CARTON contains a BOTTLE 1 240 mL in 1 BOTTLE This package is contained within the CARTON (21130-106-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201546 05/20/2011

Labeler — Safeway Inc. (009137209)

Revised: 09/2015 Safeway Inc.