Zyrtec Allergy Cetirizine HCl

Manufacturer: Jones Healthcare Group - Packaging Services, Inc
Effective date: 2026-08-19
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: daily-update
Hydrated at: 2026-09-03 03:03:29

Label at a glance#

ProductZyrtec Allergy Cetirizine HCl

Active ingredientCETIRIZINE HYDROCHLORIDE

Label structure11 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 capsule once daily; do not take more than one 10 mg capsule 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#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-343-7805

PhoneLabel contact215-273-8755

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl 10 mg

Purpose

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

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking tranquilizers or sedatives.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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 a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION


adults and children 6 years and over	one 10 mg capsule once daily; do not take more than one 10 mg capsule 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

SPL UNCLASSIFIED SECTION

• store between 20° to 25°C (68° to 77°F)
• avoid high humidity and excessive heat above 40°C (104°F)
• protect from light
• do not use if foil inner seal printed with “Sealed For Your Safety” is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylated hydroxytoluene, gelatin, glycerin, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol

Questions?

OTC - QUESTIONS SECTION

call 1-800-343-7805(toll-free) or 215-273-8755(collect)

Package Labeling: 67414-013-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Labeling: 67414-013-01 Outer Package Inner Package

Package Labeling: 67414-013-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Labeling: 67414-013-02

Outer Package2Inner Package2

Package Labeling: 67414-013-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Labeling: 67414-013-03

Outer Package3Inner Package3

Package Labeling: 67414-013-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Labeling: 67414-013-04

Outer Package4Inner Package4

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0300450204257	GTIN-13: 0300450204257 EAN-13: 0300450204257 GTIN-12: 300450204257 UPC-A: 300450204257 GTIN storage (14 digits): 00300450204257	Outer Package2.jpg
Barcode	EAN-13	0300450204318	GTIN-13: 0300450204318 EAN-13: 0300450204318 GTIN-12: 300450204318 UPC-A: 300450204318 GTIN storage (14 digits): 00300450204318	Outer Package.jpg
Barcode	EAN-13	0300450204448	GTIN-13: 0300450204448 EAN-13: 0300450204448 GTIN-12: 300450204448 UPC-A: 300450204448 GTIN storage (14 digits): 00300450204448	Outer Package3.jpg
Barcode	EAN-13	0300450206909	GTIN-13: 0300450206909 EAN-13: 0300450206909 GTIN-12: 300450206909 UPC-A: 300450206909 GTIN storage (14 digits): 00300450206909	Outer Package4.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

Zyrtec Allergy Cetirizine HCl
CETIRIZINE HYDROCHLORIDE
CETIRIZINE
BUTYLATED HYDROXYTOLUENE
GELATIN, UNSPECIFIED
GLYCERIN
POLYETHYLENE GLYCOL 400
WATER
SODIUM HYDROXIDE
SORBITAN
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67414-013	67414-013-01, 67414-013-02, 67414-013-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIM
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
GELATIN, UNSPECIFIED	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
WATER	059QF0KO0R	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
SORBITAN	6O92ICV9RU	IACT
SORBITOL	506T60A25R	IACT

Source Document#

Source XML

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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	CAPSULE / ORAL			2020-09-21

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 table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`a50c72e98297…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zyrtec Allergy Cetirizine HCl	CETIRIZINE HYDROCHLORIDE	Jones Healthcare Group - Packaging Services, Inc	59cef432-41ac-768c-e063-6294a90a38fa	2026-08-19	Warnings	Exact identifier ndc (package): 67414-013-02 ndc (package): 67414-013-03 ndc (package): 67414-013-01 ndc (product): 67414-013 ndc11 (package): 67414001302 ndc11 (package): 67414001303 ndc11 (package): 67414001301 spl id: 59cef44f-7fdf-736c-e063-6294a90ae4b6 spl set id: 59cef432-41ac-768c-e063-6294a90a38fa

Reported adverse events (FAERS/openFDA)#

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