Cetirizine Hydrochloride Tablets

Manufacturer: VERITYRX, LLC
Effective date: 2025-10-31
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 01:20:31

Label at a glance#

ProductCetirizine Hydrochloride

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)

Contacts and useful links#

PhoneLabel contact(888) 463-6332

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl, 10mg

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 if

OTC - ASK DOCTOR SECTION

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

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.

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)

Inactive ingredients

INACTIVE INGREDIENT SECTION

hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, starch, titanium dioxide.

Questions?

OTC - QUESTIONS SECTION

Any adverse reactions contact FDA (888) 463-6332 or FDA.gov/medwatch

RECENT MAJOR CHANGES SECTION

Cetirizine HCL 10MG

Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Certirizine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	1
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	1
1014678	cetirizine HCl 10 MG Oral Tablet	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CETIRIZINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	Data Matrix	(01)00383939000427(21)02481601(10)024816(17)260319	GTIN-14: 00383939000427 GTIN-12: 383939000427 UPC-A: 383939000427 EAN-13: 0383939000427 GTIN storage (14 digits): 00383939000427	Cetirizine 000402 VRX.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
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 table
Package NDC	Product	Description	Form	Quantity	SPL version
83939-0004-1	Cetirizine Hydrochloride	1 in 1 POUCH	TABLET, FILM COATED	1	1
83939-0004-2	Cetirizine Hydrochloride	1 in 1 POUCH	TABLET, FILM COATED	1	1
83939-0004-2	Cetirizine Hydrochloride	50 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	50	1
83939-0004-3	Cetirizine Hydrochloride	1 in 1 POUCH	TABLET, FILM COATED	1	1
83939-0004-3	Cetirizine Hydrochloride	100 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	100	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-811-12	EA - Each	43598-811	9da26ba6-b106-4f2c-bd31-bdc87a7141f6	1	2021-04-08
43598-811-15	EA - Each	43598-811	b8010875-5e4d-48ba-a035-b1a7cf2faaf4	1	2021-04-08

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Cetirizine Hydrochloride
Cetirizine Hydrochloride Tablets
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POVIDONE
STARCH, CORN
TITANIUM DIOXIDE
CETIRIZINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
83939-0004	83939-0004-2, 83939-0004-3, 83939-0004-1
43598-811

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
POVIDONE	FZ989GH94E	IACT
STARCH, CORN	O8232NY3SJ	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB

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 44.

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	Approval date
A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2008-01-15
A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-01-15
A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-01-15
A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2008-01-15

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 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2008-01-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2008-01-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2008-01-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2008-01-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2008-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2008-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2008-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2008-01-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2008-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2008-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2008-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2008-01-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2008-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2008-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2008-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2008-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2008-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2008-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2008-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2008-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2008-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2008-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2008-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2008-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2008-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2008-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2008-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2008-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2008-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2008-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2008-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2008-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2008-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2008-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2008-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2008-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2008-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2008-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2008-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2008-01-15	`2680178bc6a6…`

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
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE TABLETS	VERITYRX, LLC	42778a1c-6894-8646-e063-6294a90a6cb5	2025-10-31	Warnings	Exact identifier ndc (package): 83939-0004-3 ndc (package): 83939-0004-2 ndc (package): 83939-0004-1 ndc (product): 83939-0004 ndc11 (package): 83939000402 ndc11 (package): 83939000401 ndc11 (package): 83939000403 spl id: 42780c27-b003-a427-e063-6394a90ace93 spl set id: 42778a1c-6894-8646-e063-6294a90a6cb5
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE TABLETS	Dr. Reddy's Laboratories Inc.	e4eca4df-9ad8-b7c4-b512-bfaed5673789	2025-07-16	Warnings	Exact identifier ndc (product): 43598-811

Reported adverse events (FAERS/openFDA)#

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