FDA.reportPublic FDA data

Cetirizine Hydrochloride

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2021-07-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:39

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

Storage and handling

store between 20° to 25°C (68° to 77°F) TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Cetirizine Hydrochloride Tablets USP 10 mg (ALLERGY RELIEF)

 
Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

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

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.

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.

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

  • 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


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)
  • TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

call 1-800-206-7821

 

Manufactured for: Northstar Rx LLC

                           Memphis, TN 38141

Manufactured by: Aurobindo Pharma Limited

                           Hyderabad-500 090, India

Code: TS/DRUGS/19/1993

Issued: 03/2018

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2482-32023-01-30C16284748780-1f386c649-e61f-0266-e053-dadaa90a7c1ac7d1829b-2cf3-aeed-e053-2a95a90ae11a
68071-2482-72023-01-30C16284748780-1f386c649-e61f-0266-e053-dadaa90a7c1ac7d1829b-2cf3-aeed-e053-2a95a90ae11a
68071-2482-92023-01-30C16284748780-1f386c649-e61f-0266-e053-dadaa90a7c1ac7d1829b-2cf3-aeed-e053-2a95a90ae11a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2482-3Cetirizine Hydrochloride30 in 1 BOTTLETABLET301
68071-2482-7Cetirizine Hydrochloride7 in 1 BOTTLETABLET71
68071-2482-9Cetirizine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2482CETIRIZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 3 package rows20210724_c7d1829b-2cf3-aeed-e053-2a95a90ae11a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-799-01EA - Each16714-799971e322a-1c01-47bf-b15b-40357acbb8a912018-10-11
16714-799-02EA - Each16714-79955766f61-7c3f-4040-bbcd-0cd53d2f7f8c12018-08-13
16714-799-03EA - Each16714-7996e742b26-be23-46f0-89d4-b2528f12881c12018-08-13
16714-799-04EA - Each16714-799b364ac65-d4fc-4004-89f8-e1b72c7125ec12018-10-11

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
68071-248268071-2482-9, 68071-2482-3, 68071-2482-7
16714-799

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
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
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 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
A090760-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2015-08-05
A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2015-08-05
A090760-003CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2015-08-05
A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2015-08-05

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 22:38:342026-08A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-0584e616aacf4f…
2026-09-14 22:38:342026-08A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-0584e616aacf4f…
2026-09-14 22:38:342026-08A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-0584e616aacf4f…
2026-09-14 22:38:342026-08A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-0584e616aacf4f…
2026-08-18 06:07:402026-07A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-05caaa826d4ba7…
2026-08-18 06:07:402026-07A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-05caaa826d4ba7…
2026-08-18 06:07:402026-07A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-05caaa826d4ba7…
2026-08-18 06:07:402026-07A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-055bbf6a4d5a75…

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 Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDENorthStar Rx LLCc9d1e26f-c95a-4991-95fa-9ed6ed484fe22024-06-26WarningsExact identifier
ndc (product): 16714-799
c7d1829b-2cf2-aeed-e053-2a95a90ae11ac7d1829b-2cf3-aeed-e053-2a95a90ae11a2021-07-23WarningsExact identifier
spl id: c7d1829b-2cf2-aeed-e053-2a95a90ae11a
spl set id: c7d1829b-2cf3-aeed-e053-2a95a90ae11a

Reported adverse events (FAERS/openFDA)#

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