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
Zyrtec Allergy
- Manufacturer
- Kenvue Brands LLC
- Effective date
- 2025-07-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:08:05
Label at a glance#
ProductZyrtec Allergy
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10mg) in 24 hours. adults 65 years and over 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours. 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) ■ do not use if pouch is torn or damaged ■ meets USP Dissolution Test 2
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each tablet)
Cetirizine HCl 5 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
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 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.
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 right away. (1-800-222-1222)
Directions
| adults and children
6 years and over | 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10mg) in 24 hours. |
| adults 65 years and over | 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours. |
| children under 6 years of age | ask a doctor |
| consumers with liver or
kidney disease | ask a doctor |
Other information
■ store between 20° to 25°C (68° to 77°F)
■
do not use if pouch is torn or damaged
■ meets USP Dissolution Test 2
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
Questions?
call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)
PRINCIPAL DISPLAY PANEL
NDC 50580-754-15
ZYRTEC®
ALLERGY
Cetirizine HCl Tablets
5mg/antihistamine
Indoor &
Outdoor
Allergies
5mg Strength Tablets
24 Hour relief of
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
15 Tablets
5 mg each
Take 1 to 2 tablets* once daily depending on the severity of your symptoms
*Adults 65 and older take only one tablet per day
Actual Size
15 Tablets
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1014676 | cetirizine HCl 5 MG Oral Tablet | PSN | 3 |
| 1014677 | ZyrTEC 5 MG Oral Tablet | PSN | 3 |
| 1014677 | cetirizine hydrochloride 5 MG Oral Tablet [Zyrtec] | SBD | 3 |
| 1014676 | cetirizine hydrochloride 5 MG Oral Tablet | SCD | 3 |
| 1014677 | Zyrtec (cetirizine dihydrochloride 5 MG) Oral Tablet | SY | 3 |
| 1014677 | Zyrtec 5 MG Oral Tablet | SY | 3 |
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 |
|---|---|---|---|---|---|---|
| 50580-754-15 | Zyrtec Allergy | 15 in 1 CARTON | TABLET, FILM COATED | 15 | 3 | |
| 50580-754-15 | Zyrtec Allergy | 1 in 1 POUCH | TABLET, FILM COATED | 1 | 3 | |
| 50580-754-35 | Zyrtec Allergy | 35 in 1 BOTTLE | TABLET, FILM COATED | 35 | 3 | |
| 50580-754-35 | Zyrtec Allergy | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 |
Products#
Every source-derived product name is available through these pages.
- Zyrtec Allergy
- Cetirizine Hydrochloride
- POLYETHYLENE GLYCOL, UNSPECIFIED
- TITANIUM DIOXIDE
- LACTOSE MONOHYDRATE
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- CETIRIZINE
- MICROCRYSTALLINE CELLULOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50580-754 | 50580-754-35, 50580-754-15 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|---|
| N019835-003 | ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | RLD | 2007-11-16 | |
| N019835-004 | ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | |
| N019835-005 | ZYRTEC HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | RLD | 2007-11-16 | |
| N019835-006 | ZYRTEC HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | RLD | 2007-11-16 |
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 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019835-005 | ZYRTEC HIVES RELIEF | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019835-006 | ZYRTEC HIVES RELIEF | 10MG | TABLET / ORAL | RLD | 2007-11-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019835-005 | ZYRTEC HIVES RELIEF | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019835-006 | ZYRTEC HIVES RELIEF | 10MG | TABLET / ORAL | RLD | 2007-11-16 | 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 |
|---|---|---|---|---|---|---|
| Zyrtec Allergy | CETIRIZINE HYDROCHLORIDE | Kenvue Brands LLC | 2c1ecee3-c2c1-25a2-e063-6294a90aad54 | 2025-07-21 | Warnings | 50580-754-15 50580-754-35 50580-754 50580075415 50580075435 3a6e2ec1-eab8-beec-e063-6394a90aa39c 2c1ecee3-c2c1-25a2-e063-6294a90aad54 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.