Indications and uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itching of the nose or throat
Children's Zyrtec Chewable Tablets 10mg
- Manufacturer
- Kenvue Brands LLC
- Effective date
- 2026-04-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 14
- Source
- full-release
- Hydrated at
- 2026-06-01 01:54:47
Label at a glance#
ProductChildrens Zyrtec
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
may be taken with or without water chew or crush tablets completely before swallowing adults and children 6 years and over Chew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet (10 mg) 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) do not use if blister unit is torn or broken
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each chewable tablet)
Cetirizine HCl 10 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- runny nose
- itchy, watery eyes
- itching of the nose or throat
Warnings
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.
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
- in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.
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
- 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
- may be taken with or without water
- chew or crush tablets completely before swallowing
| adults and children 6 years and over | Chew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet (10 mg) 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 information
- store between 20° to 25°C (68° to 77°F)
- do not use if blister unit is torn or broken
Inactive ingredients
betadex, corn starch, flavor, lactose monohydrate, magnesium stearate, mannitol, silicified microcrystalline cellulose, sucralose
Questions?
call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)
PRINCIPAL DISPLAY PANEL
Original Prescription Strength
NDC 50580-791-03
Children's
ZYRTEC
®
ALLERGY
Cetirizine HCl
chewable tablets,
10 mg/antihistamine
Indoor &
Outdoor
Allergies
6 yrs &
older
Dye-Free
Chewables
24
Hour
Relief of
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
Actual Size
24 CHEWABLE TABLETS
Grape Flavor
Chew or crush tablets
completely before swallowing
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1014674 | cetirizine HCl 10 MG Chewable Tablet | PSN | 14 |
| 1020022 | ZyrTEC 10 MG Chewable Tablet | PSN | 14 |
| 1020022 | cetirizine hydrochloride 10 MG Chewable Tablet [Zyrtec] | SBD | 14 |
| 1014674 | cetirizine hydrochloride 10 MG Chewable Tablet | SCD | 14 |
| 1020022 | Zyrtec 10 MG Chewable Tablet | SY | 14 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CETIRIZINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Code 128 | 30061364 | Zyrtec-1.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be | Product name | 1 | 20200304 |
| a255659f-db40-429d-8c07-5f173f330d9c | Product name | 1 | 20190402 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-791-01 | Childrens Zyrtec | 4 in 1 CARTON | TABLET, CHEWABLE | 4 | 14 | |
| 50580-791-01 | Childrens Zyrtec | 6 in 1 BLISTER PACK | TABLET, CHEWABLE | 6 | 14 | |
| 50580-791-02 | Childrens Zyrtec | 8 in 1 CARTON | TABLET, CHEWABLE | 8 | 14 | |
| 50580-791-02 | Childrens Zyrtec | 6 in 1 BLISTER PACK | TABLET, CHEWABLE | 6 | 14 | |
| 50580-791-03 | Childrens Zyrtec | 1 in 1 CARTON | TABLET, CHEWABLE | 1 | 14 | |
| 50580-791-03 | Childrens Zyrtec | 6 in 1 BLISTER PACK | TABLET, CHEWABLE | 6 | 14 | |
| 50580-791-72 | Childrens Zyrtec | 3 in 1 CARTON | TABLET, CHEWABLE | 3 | 14 | |
| 50580-791-72 | Childrens Zyrtec | 24 in 1 BLISTER PACK | TABLET, CHEWABLE | 24 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-791-01 | EA - Each | 50580-791 | 2df7db41-61d7-4756-be60-253c6254843b | 1 | 2022-08-04 |
Products#
Every source-derived product name is available through these pages.
- Childrens Zyrtec
- Cetirizine hydrochloride
- BETADEX
- STARCH, CORN
- LACTOSE MONOHYDRATE
- MAGNESIUM STEARATE
- MANNITOL
- SUCRALOSE
- CETIRIZINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50580-791 | 50580-791-01, 50580-791-03, 50580-791-02, 50580-791-72 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BETADEX | JV039JZZ3A | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| CETIRIZINE HYDROCHLORIDE | 64O047KTOA | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 13 | 2026-03-24 | monthly-update | 2026-06-03 17:59:03 |
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 |
|---|---|---|---|---|---|---|---|
| N021621-003 | CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | |
| N021621-004 | CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | |
| N021621-005 | CHILDREN'S ZYRTEC HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | |
| N021621-006 | CHILDREN'S ZYRTEC HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | |
| N021621-007 | CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE / ORAL | RLD | 2020-11-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N021621-003 | CHILDREN'S ZYRTEC ALLERGY | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N021621-004 | CHILDREN'S ZYRTEC ALLERGY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N021621-005 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N021621-006 | CHILDREN'S ZYRTEC HIVES RELIEF | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N021621-007 | CHILDREN'S ZYRTEC ALLERGY | 2.5MG | TABLET, CHEWABLE / ORAL | RLD | 2020-11-30 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N021621-003 | CHILDREN'S ZYRTEC ALLERGY | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021621-004 | CHILDREN'S ZYRTEC ALLERGY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021621-005 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021621-006 | CHILDREN'S ZYRTEC HIVES RELIEF | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021621-007 | CHILDREN'S ZYRTEC ALLERGY | 2.5MG | TABLET, CHEWABLE / ORAL | RLD | 2020-11-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021621-003 | CHILDREN'S ZYRTEC ALLERGY | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021621-004 | CHILDREN'S ZYRTEC ALLERGY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021621-005 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021621-006 | CHILDREN'S ZYRTEC HIVES RELIEF | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021621-007 | CHILDREN'S ZYRTEC ALLERGY | 2.5MG | TABLET, CHEWABLE / ORAL | RLD | 2020-11-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021621-003 | CHILDREN'S ZYRTEC ALLERGY | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021621-004 | CHILDREN'S ZYRTEC ALLERGY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021621-005 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021621-006 | CHILDREN'S ZYRTEC HIVES RELIEF | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021621-007 | CHILDREN'S ZYRTEC ALLERGY | 2.5MG | TABLET, CHEWABLE / ORAL | RLD | 2020-11-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021621-003 | CHILDREN'S ZYRTEC ALLERGY | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021621-004 | CHILDREN'S ZYRTEC ALLERGY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021621-005 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021621-006 | CHILDREN'S ZYRTEC HIVES RELIEF | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021621-007 | CHILDREN'S ZYRTEC ALLERGY | 2.5MG | TABLET, CHEWABLE / ORAL | RLD | 2020-11-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021621-003 | CHILDREN'S ZYRTEC ALLERGY | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021621-004 | CHILDREN'S ZYRTEC ALLERGY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021621-005 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021621-006 | CHILDREN'S ZYRTEC HIVES RELIEF | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021621-007 | CHILDREN'S ZYRTEC ALLERGY | 2.5MG | TABLET, CHEWABLE / ORAL | RLD | 2020-11-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021621-003 | CHILDREN'S ZYRTEC ALLERGY | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021621-004 | CHILDREN'S ZYRTEC ALLERGY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021621-005 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021621-006 | CHILDREN'S ZYRTEC HIVES RELIEF | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021621-007 | CHILDREN'S ZYRTEC ALLERGY | 2.5MG | TABLET, CHEWABLE / ORAL | RLD | 2020-11-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021621-003 | CHILDREN'S ZYRTEC ALLERGY | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021621-004 | CHILDREN'S ZYRTEC ALLERGY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021621-005 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021621-006 | CHILDREN'S ZYRTEC HIVES RELIEF | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021621-007 | CHILDREN'S ZYRTEC ALLERGY | 2.5MG | TABLET, CHEWABLE / ORAL | RLD | 2020-11-30 | b8a1b40f171c… |
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 |
|---|---|---|---|---|---|---|
| Childrens Zyrtec | CETIRIZINE HYDROCHLORIDE | Kenvue Brands LLC | 0fe77356-d945-46a0-882e-b3bbab784556 | 2026-04-22 | Warnings | 50580-791-01 50580-791-02 50580-791-72 50580-791-03 50580-791 50580079101 50580079172 50580079102 50580079103 500a1503-02c8-cc05-e063-6394a90a24fb 0fe77356-d945-46a0-882e-b3bbab784556 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.