FDA.reportPublic FDA data

Cetirizine Hydrochloride Tablets, 10 mg, Allergy

Manufacturer
NuCare Pharmaceuticals, Inc.
Effective date
2026-08-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-08-22 01:01:46

Label at a glance#

ProductCetirizine Hydrochloride
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure15 sections

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#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each tablet)                                                        Purpose
Cetirizine HCl 10 mg..............................................................................................Antihistimine

OTC - PURPOSE SECTION

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

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

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

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 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

Other Information

SPL UNCLASSIFIED SECTION

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

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 for PACK Pharmaceuticals, LLC
Buffalo Grove, IL 60089, USA

Manufactured by Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),
Mumbai 400 030, India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00368071196498(21)00000000002(17)000000(10)000000GTIN-14: 00368071196498
GTIN-12: 368071196498
UPC-A: 368071196498
EAN-13: 0368071196498
GTIN storage (14 digits): 00368071196498		68071-1964-9.jpg
BarcodeEAN-130368071196498GTIN-13: 0368071196498
EAN-13: 0368071196498
GTIN-12: 368071196498
UPC-A: 368071196498
GTIN storage (14 digits): 00368071196498		68071-1964-9.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
68071-1964-12024-07-15C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-12024-07-15C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-32024-07-15C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-32024-07-15C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-72024-07-15C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-72024-07-15C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-92024-07-15C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-92024-07-15C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-12023-01-30C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-12023-01-30C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-32023-01-30C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-32023-01-30C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-72023-01-30C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-72023-01-30C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-92023-01-30C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-92023-01-30C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-12021-04-16C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-12021-04-16C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-32021-04-16C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-32021-04-16C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-72021-04-16C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-72021-04-16C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-92021-04-16C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-92021-04-16C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-12021-01-29C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-12021-01-29C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-32021-01-29C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-32021-01-29C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-72021-01-29C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-72021-01-29C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-92021-01-29C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-92021-01-29C16284748780-1ba0f9c33-2f79-a910-e053-dadaa90a0b85Cetirizine Hydrochloride Tablets, 10 mg, Allergy

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
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
68071-196468071-1964-1, 68071-1964-3, 68071-1964-9, 68071-1964-7, 68071-1964-4
16571-402

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
STARCH, CORNO8232NY3SJIACT
POLYETHYLENE GLYCOL3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
HYPROMELLOSES3NXW29V3WOIACT
LACTOSEJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-07-15full-release2026-06-01 00:15:18

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 HYDROCHLORIDENuCare Pharmaceuticals, Inc.4913192a-7364-3f19-e054-00144ff8d46c2026-08-20WarningsExact identifier
ndc (package): 68071-1964-3
ndc (package): 68071-1964-7
ndc (package): 68071-1964-9
ndc (package): 68071-1964-4
ndc (package): 68071-1964-1
ndc (product): 68071-1964
ndc11 (package): 68071196409
ndc11 (package): 68071196407
ndc11 (package): 68071196401
ndc11 (package): 68071196403
ndc11 (package): 68071196404
spl id: 597fa840-d201-db80-e063-6294a90afcb7
spl set id: 4913192a-7364-3f19-e054-00144ff8d46c
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDERising Pharma Holdings, Inc.5481ccb3-b311-4b25-b923-4fe8522ea92b2025-11-05WarningsExact identifier
ndc (product): 16571-402

Reported adverse events (FAERS/openFDA)#

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