Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy

Manufacturer
A-S Medication Solutions
Effective date
2020-01-18
Label type
Human OTC Drug Label
Version
8
Source
full-release
Hydrated at
2026-05-31 23:03:19

Label at a glance#

ProductCetirizine Hydrochloride
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure16 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

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each tablet)                                                Purpose

Cetirizine HCl USP 10 mg................................................................Antihistimine

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

WARNINGS

WARNINGS SECTION

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 DOCTOR

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

ASK DOCTOR/PHARMACIST

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

  • drowsines may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinary.

STOP USE

OTC - STOP USE SECTION

Stop use and ask a doctor if an allergic reaction tothis 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 Poison Control Center right away.

DIRECTIONS

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 overAsk a doctor
Children under 6 years of ageAsk a doctor
Consumers with liver or kidney diseaseAsk a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature]

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

QUESTIONS?

OTC - QUESTIONS SECTION

Call 1-866-562-4597

SPL UNCLASSIFIED SECTION

Manufactured by:

Unique Pharmaceutical Labs.

(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),
Mumbai 400 030, India


Distributed by:

Rising Pharmaceuticals, Inc.
Saddle Brook, NJ 07663

 

M. L. G/1430    May 2018

 

120005


Cetirizine Hydrochloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN8
1014678cetirizine hydrochloride 10 MG Oral TabletSCD8
1014678cetirizine HCl 10 MG Oral TabletSY8

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1089-0Cetirizine Hydrochloride14 in 1 BOTTLETABLET148
50090-1089-1Cetirizine Hydrochloride30 in 1 BOTTLETABLET308
50090-1089-2Cetirizine Hydrochloride100 in 1 BOTTLETABLET1008
50090-1089-3Cetirizine Hydrochloride90 in 1 BOTTLETABLET908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1089CETIRIZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]8Legacy NDC, 4 package rows20200121_b7a580d5-edfc-41b5-9713-ea18eeb9252e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1089-0EA - Each50090-10892984f35c-c9d5-41a0-bfe0-06b8fd156cbd12018-11-06
50090-1089-1EA - Each50090-108980d471a3-dd67-44fc-908b-74f0901fcacf12018-11-06
50090-1089-2EA - Each50090-1089d6b90d99-2022-4573-8472-5ad56e54a65712018-11-06
50090-1089-3EA - Each50090-108924b54ee6-67c9-4a7b-b146-1033b3e3310412018-11-06
16571-402-10EA - Each16571-4022524d8a5-6929-4792-b28d-276f9c97b20e12012-07-24
16571-402-50EA - Each16571-402a6cd2ed0-855f-460d-a2cb-5f7054e8e84912013-02-13
16571-402-90EA - Each16571-402d8ef7ec6-0a15-4216-95b1-e5296fd2d24212012-07-24

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-108950090-1089-0, 50090-1089-3, 50090-1089-1, 50090-1089-2
16571-402

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077829-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2009-08-26
A077829-002CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE10MGTABLET / ORALRS2009-08-26
A077829-003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2009-08-26
A077829-004CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2009-08-26

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-2684e616aacf4f…
2026-09-14 22:38:342026-08A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-2684e616aacf4f…
2026-09-14 22:38:342026-08A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-2684e616aacf4f…
2026-09-14 22:38:342026-08A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-2684e616aacf4f…
2026-08-18 06:07:402026-07A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-265bbf6a4d5a75…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDERising Pharma Holdings, Inc.5481ccb3-b311-4b25-b923-4fe8522ea92b2025-11-05WarningsExact identifier
ndc (product): 16571-402
16b3ec1f-f35c-4ae6-9b43-774adaee3071b7a580d5-edfc-41b5-9713-ea18eeb9252e2020-01-18WarningsExact identifier
spl id: 16b3ec1f-f35c-4ae6-9b43-774adaee3071
spl set id: b7a580d5-edfc-41b5-9713-ea18eeb9252e

Reported adverse events (FAERS/openFDA)#

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