CETIRIZINE HYDROCHLORIDE TABLETS

Manufacturer
Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals of New York, LLC
Effective date
2024-07-31
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:16:47

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 sever 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#

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Cetirizine HCl, USP 10 mg

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

INDICATIONS AND USAGE

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

● 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

OTC - STOP USE SECTION

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

PREGNANCY OR BREAST FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding:

• 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

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 AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years and overOne 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 sever 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

Other information

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

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients

lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, starch, talc and titanium dioxide.

OTC - QUESTIONS

OTC - QUESTIONS SECTION

Questions or Comments?

Call 1-877-835-5472

Monday through Friday 9AM-5PM EST

SPL UNCLASSIFIED SECTION

Distributed by: 
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 07-2024-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label
Label

SPL UNCLASSIFIED SECTION

Carton
Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN7
1014678cetirizine hydrochloride 10 MG Oral TabletSCD7
1014678cetirizine HCl 10 MG Oral TabletSY7

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
65162-046-03Cetirizine Hydrochloride1 in 1 CARTONTABLET17
65162-046-03Cetirizine Hydrochloride30 in 1 BOTTLETABLET307
65162-046-50Cetirizine Hydrochloride500 in 1 BOTTLETABLET5007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-046CETIRIZINE HYDROCHLORIDE (CETIRIZINE) TABLET [AMNEAL PHARMACEUTICALS LLC]7Current NDC, Legacy NDC, 3 package rows20240808_273172b2-9aaf-46fb-a1ce-2961650eacd3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOA6
CETIRIZINEACTIVE MOIETYYO7261ME246
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5X6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I306
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1A6
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J9906
POVIDONEINACTIVE INGREDIENTFZ989GH94E6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ6
TALCINACTIVE INGREDIENT7SEV7J4R1U6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP6

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65162-04665162-046-03, 65162-046-50

Ingredients#

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

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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 21 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POVIDONEPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET / ORAL165 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET / ORAL165 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET / ORAL165 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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
A078780-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2010-01-21
A078780-002CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2010-01-21
A078780-003CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2010-01-21
A078780-004CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2010-01-21

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 13:18:302026-09A078780-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-01-21c2088c7a36db…
2026-10-15 13:18:302026-09A078780-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2010-01-21c2088c7a36db…
2026-10-15 13:18:302026-09A078780-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2010-01-21c2088c7a36db…
2026-10-15 13:18:302026-09A078780-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-01-21c2088c7a36db…
2026-09-14 22:38:342026-08A078780-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-01-2184e616aacf4f…
2026-09-14 22:38:342026-08A078780-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2010-01-2184e616aacf4f…
2026-09-14 22:38:342026-08A078780-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2010-01-2184e616aacf4f…
2026-09-14 22:38:342026-08A078780-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-01-2184e616aacf4f…
2026-08-18 06:07:402026-07A078780-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07A078780-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2010-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07A078780-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2010-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07A078780-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-01-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078780-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078780-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2010-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078780-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2010-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078780-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078780-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078780-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2010-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078780-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2010-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078780-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078780-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078780-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2010-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078780-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2010-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078780-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078780-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078780-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2010-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078780-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2010-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078780-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-01-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078780-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-01-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078780-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2010-01-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078780-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2010-01-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078780-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-01-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078780-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-01-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078780-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2010-01-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078780-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2010-01-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078780-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-01-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078780-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-01-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078780-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2010-01-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078780-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2010-01-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078780-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-01-212680178bc6a6…

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 HydrochlorideCETIRIZINEAmneal Pharmaceuticals LLC273172b2-9aaf-46fb-a1ce-2961650eacd32024-07-31WarningsExact identifier
ndc (package): 65162-046-03
ndc (package): 65162-046-50
ndc (product): 65162-046
ndc11 (package): 65162004603
ndc11 (package): 65162004650
spl id: b1326566-e6ae-44c3-a1c5-3b0f5be3fc1f
spl set id: 273172b2-9aaf-46fb-a1ce-2961650eacd3

Reported adverse events (FAERS/openFDA)#

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