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
Cetirizine Hydrochloride Tablets USP, 10 mg
- Manufacturer
- Pioneer Life Sciences, LLC
- Effective date
- 2025-06-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:02:01
Label at a glance#
ProductALLERGY RELIEF
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure15 sections
Dosage and administration
Adults and children 6 years and older: 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
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient (in each tablet)
Cetirizine HCI USP 10 mg
Purpose
Antihistamine
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
Warnings:
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 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
Adults and children 6 years and older: 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 lnfonnation
- store between 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature).
Inactive Ingredients
hypromellose, lactose, magnesium stearate, maize starch,polyethylene glycol, povidone, titanium dioxide
Questions or Comments?
Call + 1 (732) 698 5070 & Email: info@pioneerlifesciences.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CETIRIZINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be | Product name | 1 | 20200304 |
| a255659f-db40-429d-8c07-5f173f330d9c | Product name | 1 | 20190402 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72090-028-03 | ALLERGY RELIEF | 10000 in 1 DRUM | TABLET | 10000 | 1 |
Products#
Every source-derived product name is available through these pages.
- ALLERGY RELIEF
- Cetirizine HCl
- LACTOSE MONOHYDRATE
- MAGNESIUM STEARATE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- HYPROMELLOSE, UNSPECIFIED
- TITANIUM DIOXIDE
- STARCH, CORN
- POVIDONE
- CETIRIZINE HYDROCHLORIDE
- CETIRIZINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72090-028 | 72090-028-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| POVIDONE | FZ989GH94E | IACT |
| CETIRIZINE HYDROCHLORIDE | 64O047KTOA | ACTIB |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2009-08-26 | ||
| A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | RS | 2009-08-26 | |
| A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2009-08-26 | ||
| A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2009-08-26 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 5bbf6a4d5a75… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Allergy Relief | CETIRIZINE HCL | Pioneer Life Sciences, LLC | 5249b83c-30d4-4b5b-aeb1-f52418ba079f | 2026-04-06 | Warnings | 72090-028 |
| Allergy Relief | CETIRIZINE HCL | Pioneer Life Sciences, LLC | 205b42e0-9d02-4755-9ee6-5883147abeb3 | 2025-12-23 | Warnings | 72090-028 |
| Allergy Relief | CETIRIZINE HCL | Pioneer Life Sciences, LLC | b275feae-56a1-4a60-a564-8d7b18c06aa2 | 2025-12-23 | Warnings | 72090-028 |
| ALLERGY RELIEF | CETIRIZINE HCL | Pioneer Life Sciences, LLC | 110adf3c-84ce-48a1-8a22-89ee3eec22d9 | 2025-06-01 | Warnings | 72090-028-03 72090-028 72090002803 12448b7b-e6ca-4077-96dc-f073a1ffc0e6 110adf3c-84ce-48a1-8a22-89ee3eec22d9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.