FDA.reportPublic FDA data

Cetirizine Hydrochloride Tablets

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2026-10-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-10-10 01:02:22

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 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)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl, 10mg

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

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

Stop use and ask a doctor if

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

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 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

call 1-888-375-3784.

Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130368071257090GTIN-13: 0368071257090
EAN-13: 0368071257090
GTIN-12: 368071257090
UPC-A: 368071257090
GTIN storage (14 digits): 00368071257090		68071-2570-9.jpg
Data codeData Matrix0100368071257090210000000002<GS>170000010000000<GS>68071-2570-9.jpg

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
68071-2570-32025-01-30C16284748780-1f386c64a-3f72-0266-e053-dadaa90a7c1aCetirizine Hydrochloride Tablets
68071-2570-32025-01-30C16284748780-1f386c64a-3f72-0266-e053-dadaa90a7c1aCetirizine Hydrochloride Tablets
68071-2570-72025-01-30C16284748780-1f386c64a-3f72-0266-e053-dadaa90a7c1aCetirizine Hydrochloride Tablets
68071-2570-72025-01-30C16284748780-1f386c64a-3f72-0266-e053-dadaa90a7c1aCetirizine Hydrochloride Tablets
68071-2570-92025-01-30C16284748780-1f386c64a-3f72-0266-e053-dadaa90a7c1aCetirizine Hydrochloride Tablets
68071-2570-92025-01-30C16284748780-1f386c64a-3f72-0266-e053-dadaa90a7c1aCetirizine Hydrochloride Tablets
68071-2570-32023-06-07C16284748780-1f386c64a-3f72-0266-e053-dadaa90a7c1aCetirizine Hydrochloride Tablets
68071-2570-32023-06-07C16284748780-1f386c64a-3f72-0266-e053-dadaa90a7c1aCetirizine Hydrochloride Tablets
68071-2570-72023-06-07C16284748780-1f386c64a-3f72-0266-e053-dadaa90a7c1aCetirizine Hydrochloride Tablets
68071-2570-72023-06-07C16284748780-1f386c64a-3f72-0266-e053-dadaa90a7c1aCetirizine Hydrochloride Tablets
68071-2570-92023-06-07C16284748780-1f386c64a-3f72-0266-e053-dadaa90a7c1aCetirizine Hydrochloride Tablets
68071-2570-92023-06-07C16284748780-1f386c64a-3f72-0266-e053-dadaa90a7c1aCetirizine Hydrochloride Tablets
68071-2570-32023-01-30C16284748780-1f386c64a-3f72-0266-e053-dadaa90a7c1aCetirizine Hydrochloride Tablets
68071-2570-32023-01-30C16284748780-1f386c64a-3f72-0266-e053-dadaa90a7c1aCetirizine Hydrochloride Tablets
68071-2570-72023-01-30C16284748780-1f386c64a-3f72-0266-e053-dadaa90a7c1aCetirizine Hydrochloride Tablets
68071-2570-72023-01-30C16284748780-1f386c64a-3f72-0266-e053-dadaa90a7c1aCetirizine Hydrochloride Tablets
68071-2570-92023-01-30C16284748780-1f386c64a-3f72-0266-e053-dadaa90a7c1aCetirizine Hydrochloride Tablets
68071-2570-92023-01-30C16284748780-1f386c64a-3f72-0266-e053-dadaa90a7c1aCetirizine Hydrochloride Tablets

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-811-12EA - Each43598-8119da26ba6-b106-4f2c-bd31-bdc87a7141f612021-04-08
43598-811-15EA - Each43598-811b8010875-5e4d-48ba-a035-b1a7cf2faaf412021-04-08

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
68071-257068071-2570-9, 68071-2570-3, 68071-2570-7, 68071-2570-4
43598-811

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB
HYPROMELLOSES3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONEFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32023-07-17full-release2026-05-31 23:55:40

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
A078343-001CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2008-01-15
A078343-002CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2008-01-15
A078343-003CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2008-01-15
A078343-004CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2008-01-15

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 22:38:342026-08A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-1584e616aacf4f…
2026-09-14 22:38:342026-08A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-1584e616aacf4f…
2026-09-14 22:38:342026-08A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-1584e616aacf4f…
2026-09-14 22:38:342026-08A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-1584e616aacf4f…
2026-08-18 06:07:402026-07A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-155bbf6a4d5a75…

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 HYDROCHLORIDE TABLETSDr. Reddy's Laboratories Inc.e4eca4df-9ad8-b7c4-b512-bfaed56737892025-07-16WarningsExact identifier
ndc (product): 43598-811
00b28bd2-5de0-0d73-e063-6394a90a53cdd0d89544-9f04-561c-e053-2995a90a35bd2023-07-17WarningsExact identifier
spl set id: d0d89544-9f04-561c-e053-2995a90a35bd

Reported adverse events (FAERS/openFDA)#

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