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childrens allergy relief

Rite Aid Corporation Children’s Allergy Relief Drug Facts

Approved
Approval ID

978d8779-3c00-4b21-9cc3-f6a962194dfe

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 7, 2025

Manufacturers
FDA

Rite Aid Corporation

DUNS: 014578892

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Cetirizine HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11822-1189
Application NumberANDA204226
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cetirizine HCl
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification

INGREDIENTS (7)

CETIRIZINE HYDROCHLORIDEActive
Quantity: 5 mg in 5 mL
Code: 64O047KTOA
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/7/2025

Package/Label Principal Display Panel

Compare to the active ingredient in Children’s Zyrtec®

FREE FROM

DYE FREE

SUGAR FREE

FOR AGES 2 YEARS & OLDER

CHILDREN’S ALLERGY RELIEF

CETIRIZINE HYDROCHLORIDE ORAL SOLUTION 1 mg/mL ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

24 HOUR RELIEF OF

Sneezing • Runny nose

Itchy, watery eyes

Itchy throat or nose

DYE FREE

BUBBLEGUM FLAVOR

DOSING CUP INCLUDED

4 FL OZ (120 mL)

![189-83-childrens-allergy- relief.jpg](/dailymed/image.cfm?name=189-83-childrens-allergy- relief.jpg&id=874828)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/4/2020

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/4/2020

Active ingredient (in each 5 mL)

Cetirizine HCl 5 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 3/4/2020

Purpose

Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 3/4/2020

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)

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/7/2025

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/7/2025

Other information

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

**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 INGREDIENT SECTION

LOINC: 51727-6Updated: 3/4/2020

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/7/2025

Questions or comments?

1-800-719-9260

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childrens allergy relief - FDA Drug Approval Details