FDA.reportPublic FDA data

Cetirizine Hydrochloride

Manufacturer
Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2021-05-06
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-05-31 23:40:13

Label at a glance#

ProductCetirizine Hydrochloride
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure14 sections

Indications and 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

Dosage and administration

Tablet melts in mouth. Can be taken with or without water. 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

store between 20° to 25°C (68° to 77°F). Avoid high humidity. do not use if carton or blister unit is opened or broken   see side panel for lot number and expiration date

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Cetirizine hydrochloride USP 10 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking tranquilizers or sedatives.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

Tablet melts in mouth. Can be taken with or without water.

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

Other information

STORAGE AND HANDLING SECTION

  • store between 20° to 25°C (68° to 77°F). Avoid high humidity.
  • do not use if carton or blister unit is opened or broken 
  • see side panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

betadex, citric acid anhydrous, colloidal silicon dioxide, crospovidone, dl-alpha-tocopherol, hydroxypropyl cellulose, magnesium stearate, maize maltodextrin, mannitol, microcrystalline cellulose, natural flavourings, sodium bicarbonate, sodium starch glycolate and sucralose.

Questions or comments?
call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)


Distributed by: AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520  

Made in India

Code: AP/DRUGS/04/2016


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (24 Orally Disintegrating Tablets) Blister Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Healthy Living™
NDC 58602-860-76
*Compare to the active
ingredient of Zyrtec® Allergy
Original Prescription Strength
 Cetirizine Hydrochloride
Orally Disintegrating Tablets, USP 10 mg
 Antihistamine
Allergy
Dissolve Tabs
Melts In Your Mouth
ORANGE FLAVOR
Indoor + Outdoor Allergies 
 24 Hour Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose


Actual Size

24 Orally Disintegrating Tablets
10 mg each

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (12 Orally Disintegrating Tablets) Blister CartonPACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (12 Orally Disintegrating Tablets) Blister Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1011482cetirizine HCl 10 MG Disintegrating Oral TabletPSN2
1011482cetirizine hydrochloride 10 MG Disintegrating Oral TabletSCD2
1011482cetirizine HCl 10 MG Disintegrating Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CETIRIZINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-860-76Cetirizine Hydrochloride4 in 1 CARTONTABLET, ORALLY DISINTEGRATING42
58602-860-76Cetirizine Hydrochloride6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-860CETIRIZINE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [AUROHEALTH LLC]2Current NDC, Legacy NDC, 2 package rows20210508_c111f6f3-e190-447f-b4a4-e277af641483.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-86058602-860-76

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB
BETADEXJV039JZZ3AIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSPOVIDONE (35 .MU.M)40UAA97IT9IACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)5Y0974F5PWIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MANNITOL3OWL53L36AIACT
MICROCRYSTALLINE CELLULOSE 1017T9FYH5QMKIACT
MICROCRYSTALLINE CELLULOSE 102PNR0YF693YIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213557-001CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-1184e616aacf4f…
2026-08-18 06:07:402026-07A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-114b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-11c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-11cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213557-001CETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-11a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEAurohealth LLCc111f6f3-e190-447f-b4a4-e277af6414832021-05-06WarningsExact identifier
ndc (package): 58602-860-76
ndc (product): 58602-860
ndc11 (package): 58602086076
spl id: 99f8f81a-d083-48c1-a923-4ed0dfcd989f
spl set id: c111f6f3-e190-447f-b4a4-e277af641483

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.