Cetirizine Hydrochloride Tablets USP 5 mg, Allergy

Manufacturer
Proficient Rx LP
Effective date
2019-10-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:01:20

Label at a glance#

ProductCetirizine Hydrochloride
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

Dosage and administration

Adults and children 6years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours Adults 65 years and over 1 tablet once a day; do not take more than 1 tablet in 24 hours 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 (IN EACH TABLET)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl USP 5 mg

PURPOSE

OTC - PURPOSE SECTION

Antihistimine

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

SPL UNCLASSIFIED 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

SPL UNCLASSIFIED 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

SPL UNCLASSIFIED SECTION

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

WHEN USING THIS PRODUCT

SPL UNCLASSIFIED 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

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

IF PREGNANT OR BREAST-FEEDING

SPL UNCLASSIFIED 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. (1-800-222-1222)

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION


Adults and children 6years and over


1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours


Adults 65 years and over


1 tablet once a day; do not take more than 1 tablet in 24 hours


Children under 6 years of age


Ask a doctor


Consumers with liver or kidney disease


Ask 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

120004

Repackaged By;

Proficient Rx LP

Thousand Oaks 91320

Cetirizine Hydrochloride Tablets USP 5 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71205-093-30

Original Prescription Strength

Cetirizine Hydrochloride
Tablets 5 mg

30 Tablets

71205-093-30
71205-093-30

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014676cetirizine HCl 5 MG Oral TabletPSN3
1014676cetirizine hydrochloride 5 MG Oral TabletSCD3

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
71205-093-15Cetirizine Hydrochloride15 in 1 BOTTLETABLET153
71205-093-30Cetirizine Hydrochloride30 in 1 BOTTLETABLET303
71205-093-60Cetirizine Hydrochloride60 in 1 BOTTLETABLET603
71205-093-90Cetirizine Hydrochloride90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-093CETIRIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 4 package rows20191029_9c2b97d9-9990-46ab-9027-c34ffb07ce8f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-093-30EA - Each71205-0938f17a15d-153e-4148-b386-3ccf64bd47fa12018-10-11
16571-401-10EA - Each16571-401eab5f61f-c1c6-4d23-a3d5-c91ffde369b412012-07-24

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
71205-09371205-093-15, 71205-093-30, 71205-093-60, 71205-093-90
16571-401

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 44.

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 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-26c2088c7a36db…
2026-10-15 13:18:302026-09A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-26c2088c7a36db…
2026-10-15 13:18:302026-09A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-26c2088c7a36db…
2026-10-15 13:18:302026-09A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-26c2088c7a36db…
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…

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.6493d4f6-dead-45ec-ade1-28ce624af33d2024-02-22WarningsExact identifier
ndc (product): 16571-401
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEProficient Rx LP9c2b97d9-9990-46ab-9027-c34ffb07ce8f2019-10-01WarningsExact identifier
ndc (package): 71205-093-90
ndc (package): 71205-093-15
ndc (package): 71205-093-60
ndc (package): 71205-093-30
ndc (product): 71205-093
ndc11 (package): 71205009315
ndc11 (package): 71205009390
ndc11 (package): 71205009360
ndc11 (package): 71205009330
spl id: 26beeb96-f0b4-4e99-ba9d-3b27c67659dc
spl set id: 9c2b97d9-9990-46ab-9027-c34ffb07ce8f

Reported adverse events (FAERS/openFDA)#

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