Zyrtec

Manufacturer: Savings Distributors LLC
Effective date: 2026-06-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: monthly-update
Hydrated at: 2026-07-17 21:34:47

Label at a glance#

ProductZyrtec Allergy

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 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) do not use if pouch is torn or damaged meets USP Dissolution Test 2

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-343-7805

PhoneLabel contact215-273-8755

Websitewww.zyrtec.com

www.zyrtec.com

Websitewww.jjcipats.com

www.jjcipats.com

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

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

OTC - DO NOT USE SECTION

Do not useif 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 haveliver 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 aretaking 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

OTC - STOP USE SECTION

Stop use and ask a doctor ifan 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.

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

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Active ingredient made in Switzerland

Distributed by:

JOHNSON & JOHNSON CONSUMER INC.

McNeil Consumer Healthcare Division

Fort Washington, PA 19034 USA

@J&JCI 2024 www.zyrtec.com

Pat. www.jjcipats.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Original Prescription Strength

ZYRTEC ^®
ALLERGY

Cetirizine HCl tablets
10 mg /antihistamine

Indoor & Outdoor Allergies

24 hour

Relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

20 Pouches of 1 Tablet per pouch
10 mg each (Individual Pouches)

label

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Data Matrix	30053207		Zyrtec label.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-726-30	EA - Each	50580-726	853bd501-594a-43ba-8d6e-e570fc3ab764	1	2012-07-24
50580-726-32	EA - Each	50580-726	075b55b7-dbdc-464a-b6a4-6071a07901fc	1	2012-07-24
50580-726-36	EA - Each	50580-726	4159f1d6-19ba-4c79-8ede-b5d73ee883fb	1	2012-07-24
50580-726-38	EA - Each	50580-726	6ad75859-5196-4c44-a976-8da28a0c95e9	1	2012-07-24
50580-726-51	EA - Each	50580-726	a2ed8aaf-f19c-4a7e-8aff-41d2a0f3ec96	1	2012-07-24
50580-726-93	EA - Each	50580-726	c0eb6ce2-976c-4e27-af1f-c011ac402eb8	1	2018-10-11
50580-726-96	EA - Each	50580-726	82123398-20e6-4b44-bba9-0c664a14a66e	1	2022-08-04

Products#

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

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

Zyrtec Allergy
Cetirizine Hydrochloride
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
CETIRIZINE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
73097-016	73097-016-20
50580-726

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
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	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.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Savings Distributors LLC	5490c38a-91d7-9ee1-e063-6394a90a1ea5	2026-06-01	Warnings	Exact identifier ndc (package): 73097-016-20 ndc (product): 73097-016 ndc11 (package): 73097001620 spl id: 5490c38a-91d8-9ee1-e063-6394a90a1ea5 spl set id: 5490c38a-91d7-9ee1-e063-6394a90a1ea5
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	b165db38-b302-4220-8627-77cb07bb078c	2025-10-10	Warnings	Exact identifier ndc (product): 50580-726

Reported adverse events (FAERS/openFDA)#

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