DailyMed - CHILDRENS CETIRZINE- cetirizine hydrochloride solution

NDC Code(s): 68016-106-08
Packager: Pharmacy Value Alliance LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 12, 2017

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SPL UNCLASSIFIED SECTION
Drug Facts

Drug Facts
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Active ingredient (in each 5 mL)
Cetirizine HCl 5 mg

Cetirizine HCl 5 mg
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Purpose
Antihistamine

Antihistamine
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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
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
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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 ...
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)

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Directions

use only with enclosed dosing cup - find right dose on chart below - mL = milliliter - adults and children 6 years and over5 mL or 10 mL once daily depending upon severity of symptoms; do not ...

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

bubble gum artificial flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate anhydrous, sucralose
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Questions?
Call 1-866-923-4914

Call 1-866-923-4914
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SPL UNCLASSIFIED SECTION
Distributed By: Pharmacy Value Alliance, LLC - 407 East Lancaster Avenue - Wayne, PA 19087

Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue
Wayne, PA 19087
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PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
COMPARE TO THE - ACTIVE INGREDIENT - IN CHILDREN'S ZYRTEC®* Premier - Value® 2 Yrs. & older - Children's - Cetirizine - Hydrochloride - Oral Solution - 1 mg/mL - Antihistamine - Allergy - SUGAR FREE - BUBBLE ...
COMPARE TO THE
ACTIVE INGREDIENT
IN CHILDREN'S ZYRTEC®*

Premier
Value®

2 Yrs.
& older

Children's
Cetirizine
Hydrochloride
Oral Solution
1 mg/mL
Antihistamine

Allergy

SUGAR FREE
BUBBLE GUM flavor

INDOOR & OUTDOOR ALLERGIES

24 Hour Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
Dosing Cup
Included

4 FL OZ
(120 mL)

INDEPENDENTLY TESTED
SATISFACTION GUARANTEED
PV

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INGREDIENTS AND APPEARANCE

Product Information

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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

Published Date (What is this?)	Version	Files
Jun 13, 2017	3 (current)	download
Mar 27, 2014	2	download
Dec 6, 2012	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1014673	cetirizine HCl 5 MG in 5 mL Oral Solution	PSN
2	1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD
3	1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY
4	1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY

Label: CHILDRENS CETIRZINE- cetirizine hydrochloride solution

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Label: CHILDRENS CETIRZINE- cetirizine hydrochloride solution

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CHILDRENS CETIRZINE- cetirizine hydrochloride solution

Number of versions: 3

CHILDRENS CETIRZINE- cetirizine hydrochloride solution

CHILDRENS CETIRZINE- cetirizine hydrochloride solution

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CHILDRENS CETIRZINE- cetirizine hydrochloride solution

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