DailyMed - DYE FREE CHILDRENS CETIRIZINE HYDROCHOLRIDE- cetirizine hcl solution

NDC Code(s): 68094-004-59, 68094-004-62
Packager: Precision Dose, Inc.
This is a repackaged label.
Source NDC Code(s): 0113-0503

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

Drug Label Information

Updated February 12, 2025

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SPL UNCLASSIFIED SECTION
5 mg/5 mL Grape Flavor - For Hospital Use Only - LI1660 Rev.10/24 - Drug Facts

5 mg/5 mL Grape Flavor

For Hospital Use Only

LI1660 Rev.10/24

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 as directed per healthcare professional. mL = milliliter - adults and children 6 years and over5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL ...

Other Information
store between 20° to 25°C (68° to 77°F)
- store between 20° to 25°C (68° to 77°F)
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Inactive ingredients
anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose
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SPL UNCLASSIFIED SECTION
Dye Free, Gluten Free, Sugar Free

Dye Free, Gluten Free, Sugar Free
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How Supplied
NDC 68094-004-62 - 5 mL per unit dose cup - Thirty (30) cups per shipper

NDC 68094-004-62
5 mL per unit dose cup
Thirty (30) cups per shipper
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SPL UNCLASSIFIED SECTION
Packaged By: Precision Dose, Inc. South Beloit, IL 61080 - For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com. LI1660 Rev.10/24

Packaged By:
Precision Dose, Inc.
South Beloit, IL 61080

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com.

LI1660 Rev.10/24
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PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
NDC 68094-004-59 - PrecisionDose ™ Children's CETIRIZINE HCl - Oral Solution - 5 mg/5 mL - DYE - FREE - Pkg: Precision Dose, Inc., S. Beloit, IL 61080

NDC 68094-004-59
PrecisionDose ™

Children's CETIRIZINE HCl
Oral Solution
5 mg/5 mL
DYE
FREE

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

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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
Feb 17, 2025	3 (current)	download
Sep 5, 2024	2	download
Nov 17, 2016	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: DYE FREE CHILDRENS CETIRIZINE HYDROCHOLRIDE- cetirizine hcl solution

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	NDC
1	68094-004-59
2	68094-004-62

Label: DYE FREE CHILDRENS CETIRIZINE HYDROCHOLRIDE- cetirizine hcl solution

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DYE FREE CHILDRENS CETIRIZINE HYDROCHOLRIDE- cetirizine hcl solution

Number of versions: 3

DYE FREE CHILDRENS CETIRIZINE HYDROCHOLRIDE- cetirizine hcl solution

DYE FREE CHILDRENS CETIRIZINE HYDROCHOLRIDE- cetirizine hcl solution

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DYE FREE CHILDRENS CETIRIZINE HYDROCHOLRIDE- cetirizine hcl solution

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.