MedPath

allergy relief

Walgreen Co. Allergy Relief Drug Facts

Approved
Approval ID

678dcc09-55da-4d9d-a39a-c450c61c387b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 18, 2025

Manufacturers
FDA

Walgreen Company

DUNS: 008965063

Products 1

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

Cetirizine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0363-4101
Application NumberANDA078336
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cetirizine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2025
FDA Product Classification

INGREDIENTS (11)

CETIRIZINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 64O047KTOA
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/18/2025

Principal Display Panel

ORIGINAL PRESCRIPTION STRENGTH

Walgreens

WALGREENS PHARMACIST RECOMMENDED

Compare to the active ingredient in Zyrtec®

Allergy Relief

24 HOUR ALLERGY

CETIRIZINE HYDROCHLORIDE TABLETS 10 mg / ANTIHISTAMINE

24 Hour

Indoor & Outdoor Allergies

• Relief of sneezing; runny nose; itchy, watery eyes & itchy throat or nose

90 TABLETS

ACTUAL SIZE

10 mg each

![walgreens-allergy-relief-carton- image.jpg](/dailymed/image.cfm?name=walgreens-allergy-relief-carton- image.jpg&id=898511)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/16/2021

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: 6/16/2021

Active ingredient (in each tablet)

Cetirizine HCl 10 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/16/2021

Purpose

Antihistamine

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 10/21/2021

Questions or comments?

1-800-719-9260

WARNINGS SECTION

LOINC: 34071-1Updated: 6/16/2021

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: 9/18/2025

Directions

adults and children 6 years and over

one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

adults 65 years and over

ask a doctor

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 10/21/2021

Other information

store between 20-25°C (68-77°F)

do not use if printed foil under cap is broken or missing

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/21/2021

Inactive ingredients

corn starch, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

allergy relief - FDA Drug Approval Details