Cetirizine HCl

Manufacturer: Bionpharma Inc. | Patheon Softgels Inc.
Effective date: 2025-12-16
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 01:25:33

Label at a glance#

ProductCetirizine HCl

Active ingredientCETIRIZINE HYDROCHLORIDE

Label structure10 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

Storage and handling

store at 20º-25ºC (68º-77ºF) avoid high humidity and excessive heat above 40ºC (104ºF) protect from light

Contacts and useful links#

PhoneLabel contact1-888-235-2466

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
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
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 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

STORAGE AND HANDLING SECTION

store at 20º-25ºC (68º-77ºF)
avoid high humidity and excessive heat above 40ºC (104ºF)
protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

call toll free 1-888-235-2466(Mon - Fri 9AM - 5PM EST)

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP THIS CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

^†This product is not manufactured or distributed by the owners of Zyrtec®

Manufactured for:

BIONPHARMA

Princeton, NJ 08540

R0921

L0000534

Principal Display Panel - 65's carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

^†compare tothe active ingredient in Zyrtec^®

NDC 69452-265-88

a+health ^TM

cetirizine HCl capsules, 10 mg

antihistamine

indoor & outdoor allergies

24 hour relief of:

sneezing
runny nose
itchy, watery eyes
itchy throat or nose

65 softgels**

**liquid-filled capsule

carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1014675	cetirizine HCl 10 MG 24HR Oral Capsule	PSN	5
1014675	cetirizine hydrochloride 10 MG Oral Capsule	SCD	5
1014675	cetirizine HCl 10 MG 24 HR Oral Capsule	SY	5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
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 table
Package NDC	Product	Description	Form	Quantity	SPL version
69452-265-15	Cetirizine HCl	1 in 1 CARTON	CAPSULE	1	5
69452-265-15	Cetirizine HCl	40 in 1 BOTTLE, PLASTIC	CAPSULE	40	5
69452-265-86	Cetirizine HCl	25 in 1 BOTTLE, PLASTIC	CAPSULE	25	5
69452-265-86	Cetirizine HCl	1 in 1 CARTON	CAPSULE	1	5
69452-265-88	Cetirizine HCl	65 in 1 BOTTLE, PLASTIC	CAPSULE	65	5
69452-265-88	Cetirizine HCl	1 in 1 CARTON	CAPSULE	1	5

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Cetirizine HCl
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
MANNITOL
POLYETHYLENE GLYCOL, UNSPECIFIED
WATER
SODIUM HYDROXIDE
SORBITAN
SORBITOL
CETIRIZINE HYDROCHLORIDE
CETIRIZINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69452-265	69452-265-86, 69452-265-15, 69452-265-88

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
MANNITOL	3OWL53L36A	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
WATER	059QF0KO0R	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
SORBITAN	6O92ICV9RU	IACT
SORBITOL	506T60A25R	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 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
N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	RLD	2009-07-23
N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23
N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	RLD	2009-07-23
N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23

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	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine HCl	CETIRIZINE HCL	Bionpharma Inc.	2c2c4828-0479-4ff3-b2b0-dde5fa74efaf	2025-12-16	Warnings	Exact identifier ndc (package): 69452-265-88 ndc (package): 69452-265-86 ndc (package): 69452-265-15 ndc (product): 69452-265 ndc11 (package): 69452026588 ndc11 (package): 69452026515 ndc11 (package): 69452026586 spl id: 46133ef3-fe73-3341-e063-6394a90adc6d spl set id: 2c2c4828-0479-4ff3-b2b0-dde5fa74efaf

Reported adverse events (FAERS/openFDA)#

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