FDA.reportPublic FDA data

Cetirizine Hydrochloride - First Nation Group, LLC | Contract Pharmacal Corp.

Manufacturer
First Nation Group, LLC | Contract Pharmacal Corp.
Effective date
2026-09-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-10-06 02:02:03

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#

OTC - ACTIVE INGREDIENT SECTION

Cetirizine Hydrochloride 10 mg, 5 mg

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 SECTION

OTC - DO NOT USE 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/PHARMACIST SECTION

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 taking sedatives or tranquilizers.

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding:

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.

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 (1-800-222-1222) 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 INGREDIENT SECTION

Hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate, povidone, pregelatinized starch, and titanium dioxide.

QUESTIONS

DESCRIPTION SECTION

1-855-221-5332: Weekdays 9AM - 5PM EST

SPL UNCLASSIFIED SECTION

DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured For: First Nation Group, LLC
4566 E Highway 20, Suite #208, Niceville, FL 32578-8839

* This product is not manufactured or distributed by Kenvue Brands LLC., the owner of the registered trademark Zyrtec®.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 81469-353-01

Compares to Zyrtec®Allergy Original Prescription Strength

Indoor & Outdoor Allergies

Cetirizine HCl

Tablets, USP 100 Tablets

10mg/ Antihistamine

24 Hour

Relief of Sneezing, Runny Nose,

Itchy, Watery Eyes, Itchy Throat or Nose

FIRSTNATION Group

Observation MediaObservation Media

NDC 81469-352-01

Compares to Zyrtec®Allergy Original Prescription Strength

Indoor & Outdoor Allergies

Cetirizine HCl

Tablets, USP 100 Tablets

5mg/ Antihistamine

24 Hour

Relief of Sneezing, Runny Nose,

Itchy, Watery Eyes, Itchy Throat or Nose

FIRSTNATION Group

NDC 81469-352-01NDC 81469-352-01

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
81469-35381469-353-90, 81469-353-03, 81469-353-05, 81469-353-01
81469-35281469-352-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB
HYPROMELLOSES3NXW29V3WOIACT
POVIDONE K30U725QWY32XIACT
POLYSORBATE 806OZP39ZG8HIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
MAGNESIUM STEARATE70097M6I30IACT
STARCH, CORNO8232NY3SJIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB
HYPROMELLOSES3NXW29V3WOIACT
POVIDONE K30U725QWY32XIACT
POLYSORBATE 806OZP39ZG8HIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
MAGNESIUM STEARATE70097M6I30IACT
STARCH, CORNO8232NY3SJIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-06-03full-release2026-06-05 00:30:39

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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076047-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-27
A076047-002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-27

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-08-18 06:07:402026-07A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076047-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076047-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2774a2ff9319b5…

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 HydrochlorideCETIRIZINE HYDROCHLORIDEFirst Nation Group, LLC5267f7c0-e62f-35da-e063-6394a90a93462026-06-03WarningsExact identifier
ndc (package): 81469-353-03
ndc (package): 81469-353-05
ndc (package): 81469-353-90
ndc (package): 81469-353-01
ndc (product): 81469-353
ndc11 (package): 81469035301
ndc11 (package): 81469035303
ndc11 (package): 81469035305
ndc11 (package): 81469035390
spl set id: 5267f7c0-e62f-35da-e063-6394a90a9346

Reported adverse events (FAERS/openFDA)#

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