FDA.reportPublic FDA data

Cetirizine HCl

Manufacturer
GERI-CARE PHARMACEUTICAL CORP
Effective date
2025-04-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:42

Label at a glance#

ProductCetirizine HCl
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure10 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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl 10 mg

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

Warnings

WARNINGS SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or 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 sedatives or tranquilizers

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate, povidone,
pregelatinized starch, and titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765
Weekdays 9AM-5PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN1
1014678cetirizine hydrochloride 10 MG Oral TabletSCD1
1014678cetirizine HCl 10 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-992-01Cetirizine HCl100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-992CETIRIZINE HCL (CETIRIZINE) TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP]1Current NDC, 1 package rows20250426_3389e947-b7d1-6caf-e063-6294a90a2238.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-992-01EA - Each57896-992739d9b15-ec1f-4f09-9148-4c0c4bf606d812025-09-12

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57896-99257896-992-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYSORBATE 806OZP39ZG8HIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB

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 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076047-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-27
A076047-002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-27

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.

Product history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27c2088c7a36db…
2026-10-15 13:18:302026-09A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27c2088c7a36db…
2026-09-14 22:38:342026-08A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-08-18 06:07:402026-07A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-274b0b4de00fa7…

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 HClCETIRIZINEGERI-CARE PHARMACEUTICAL CORP3389e947-b7d1-6caf-e063-6294a90a22382025-04-24WarningsExact identifier
ndc (package): 57896-992-01
ndc (product): 57896-992
ndc11 (package): 57896099201
spl id: 3389e955-a045-abfd-e063-6394a90a4e02
spl set id: 3389e947-b7d1-6caf-e063-6294a90a2238

Reported adverse events (FAERS/openFDA)#

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