CETIRIZINE HYDROCHLORIDE

Manufacturer: Bionpharma Inc. | OrBion Pharmaceuticals Private Limited
Effective date: 2025-12-08
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:20:41

Label at a glance#

ProductCETIRIZINE HYDROCHLORIDE

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 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 contact1-888-235-2466

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine Hydrochloride USP, 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.

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

Stop use and ask a doctor ifan allergic reaction to this product occurs. Seek medical help right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

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

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

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-888-235-2466

SPL UNCLASSIFIED SECTION

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

Distributed by:

BIONPHARMA

Princeton, NJ 08540

MADE IN INDIA
Code: TN/Drugs/TN00002222/2006

L0001172

R1025

948006938

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

'compare to the active ingredient in Zyrtec ^® Allergy

a+health ^TM

original prescription strength

allergy relief

cetirizine HCl tablets USP, 10 mg

antihistamine

6 years and older

indoor & outdoor allergies

24 hour relief of:

sneezing
runny nose
itchy, watery eyes
itchy, throat or nose

400 tablets

label

label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	2
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	2
1014678	cetirizine HCl 10 MG Oral Tablet	SY	2

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
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	Strength	SPL version
69452-465-81	CETIRIZINE HYDROCHLORIDE	400 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	400		2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

CETIRIZINE HYDROCHLORIDE
STARCH, CORN
LACTOSE MONOHYDRATE
POVIDONE K29/32
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (5 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
CETIRIZINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69452-465	69452-465-81

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
STARCH, CORN	O8232NY3SJ	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
POVIDONE K29/32	390RMW2PEQ	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	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
A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2009-02-19
A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2009-02-19
A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2009-02-19
A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2009-02-19

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	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	Bionpharma Inc.	831d4141-b3be-4d98-a372-9c4d57ad296c	2025-12-08	Warnings	Exact identifier ndc (package): 69452-465-81 ndc (product): 69452-465 ndc11 (package): 69452046581 spl id: 45745bf3-a132-b51a-e063-6394a90a712e spl set id: 831d4141-b3be-4d98-a372-9c4d57ad296c

Reported adverse events (FAERS/openFDA)#

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