MedPath

cetirizine hydrochloride

Perrigo Cetirizine Hydrochloride Tablets 10 mg Drug Facts

Approved
Approval ID

ae93976d-de9b-43a6-b299-ce1f1ae8d6f8

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 21, 2025

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

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 Code72162-2173
Application NumberANDA078336
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cetirizine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 21, 2025
FDA Product Classification

INGREDIENTS (11)

CETIRIZINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 64O047KTOA
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
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
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/21/2025

Cetirizine Hydrochloride 10mg Tablet

Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/27/2016

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: 6/18/2024

Active ingredient (in each tablet)

Cetirizine HCl 10 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/26/2009

Purpose

Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 7/27/2016

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: 7/27/2016

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: 7/27/2016

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: 9/20/2016

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 11/9/2021

Questions or comments?

1-800-719-9260

How Supplied Section

LOINC: 34069-5Updated: 5/21/2025

HOW SUPPLIED

Cetirizine Hydrochloride 10mg Tablet

  • NDC 72162-2173-2: 300 Tablets in a BOTTLE
  • NDC 72162-2173-3: 30 Tablets in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

cetirizine hydrochloride - FDA Drug Approval Details