Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy

Manufacturer: Bryant Ranch Prepack
Effective date: 2024-07-25
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-06-01 00:16:01

Label at a glance#

ProductCetirizine Hydrochloride

Active ingredientCETIRIZINE HYDROCHLORIDE

Label structure17 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

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-844-874-7464

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet)

Cetirizine HCl 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

Do Not Use if 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 have liver 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 are taking tranquilizers or sedatives.

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if an allergic reaction tothis 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 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:

SPL UNCLASSIFIED SECTION

store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

Questions?

OTC - QUESTIONS SECTION

Call 1-844-874-7464

SPL UNCLASSIFIED SECTION

Manufactured by:

Unique Pharmaceutical Labs.

(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),
Mumbai 400 030, India

Distributed by:

Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

M. L. G/1430 Jul. 2020

126406

HOW SUPPLIED

How Supplied Section

NDC: 71335-0300-1: 30 Tablets in a BOTTLE

NDC: 71335-0300-2: 14 Tablets in a BOTTLE

NDC: 71335-0300-3: 7 Tablets in a BOTTLE

NDC: 71335-0300-4: 10 Tablets in a BOTTLE

NDC: 71335-0300-5: 15 Tablets in a BOTTLE

NDC: 71335-0300-6: 90 Tablets in a BOTTLE

NDC: 71335-0300-7: 20 Tablets in a BOTTLE

NDC: 71335-0300-8: 60 Tablets in a BOTTLE

NDC: 71335-0300-9: 100 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cetirizine Hydrochloride 10 mg Tablet

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	9
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	9
1014678	cetirizine HCl 10 MG Oral Tablet	SY	9

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	SPL version
71335-0300-1	Cetirizine Hydrochloride	30 in 1 BOTTLE	TABLET	30	9
71335-0300-2	Cetirizine Hydrochloride	14 in 1 BOTTLE	TABLET	14	9
71335-0300-3	Cetirizine Hydrochloride	7 in 1 BOTTLE	TABLET	7	9
71335-0300-4	Cetirizine Hydrochloride	10 in 1 BOTTLE	TABLET	10	9
71335-0300-5	Cetirizine Hydrochloride	15 in 1 BOTTLE	TABLET	15	9
71335-0300-6	Cetirizine Hydrochloride	90 in 1 BOTTLE	TABLET	90	9
71335-0300-7	Cetirizine Hydrochloride	20 in 1 BOTTLE	TABLET	20	9
71335-0300-8	Cetirizine Hydrochloride	60 in 1 BOTTLE	TABLET	60	9
71335-0300-9	Cetirizine Hydrochloride	100 in 1 BOTTLE	TABLET	100	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0300	CETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	9	Current NDC, Legacy NDC, 9 package rows	20240726_4b192084-dfdc-47bc-a968-6f49e137b248.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0300-1	EA - Each	71335-0300	e20488a2-34f2-42a1-9464-785c88d71887	1	2018-04-19
71335-0300-2	EA - Each	71335-0300	1e1d2893-c766-4168-9b20-a69ce74ba67f	1	2018-04-19
71335-0300-6	EA - Each	71335-0300	20ca9a0b-511e-439b-a5da-2460e49d5af2	1	2018-04-19
16571-402-10	EA - Each	16571-402	2524d8a5-6929-4792-b28d-276f9c97b20e	1	2012-07-24
16571-402-50	EA - Each	16571-402	a6cd2ed0-855f-460d-a2cb-5f7054e8e849	1	2013-02-13
16571-402-90	EA - Each	16571-402	d8ef7ec6-0a15-4216-95b1-e5296fd2d242	1	2012-07-24

Products#

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

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

Cetirizine Hydrochloride
CETIRIZINE
HYPROMELLOSE, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
STARCH, CORN
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71335-0300	71335-0300-1, 71335-0300-2, 71335-0300-3, 71335-0300-4, 71335-0300-5, 71335-0300-6, 71335-0300-7, 71335-0300-8, 71335-0300-9
16571-402

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
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
LACTOSE, UNSPECIFIED FORM	J2B2A4N98G	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
STARCH, CORN	O8232NY3SJ	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
TITANIUM DIOXIDE	15FIX9V2JP	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 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	RLD / RS	Approval date
A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL		2009-08-26
A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	RS	2009-08-26
A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL		2009-08-26
A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2009-08-26

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	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`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	Rising Pharma Holdings, Inc.	5481ccb3-b311-4b25-b923-4fe8522ea92b	2025-11-05	Warnings	Exact identifier ndc (product): 16571-402
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Bryant Ranch Prepack	4b192084-dfdc-47bc-a968-6f49e137b248	2024-07-25	Warnings	Exact identifier ndc (package): 71335-0300-3 ndc (package): 71335-0300-5 ndc (package): 71335-0300-4 ndc (package): 71335-0300-7 ndc (package): 71335-0300-8 ndc (package): 71335-0300-2 ndc (package): 71335-0300-1 ndc (package): 71335-0300-6 ndc (package): 71335-0300-9 ndc (product): 71335-0300 ndc11 (package): 71335030008 ndc11 (package): 71335030007 ndc11 (package): 71335030002 ndc11 (package): 71335030004 ndc11 (package): 71335030003 ndc11 (package): 71335030001 ndc11 (package): 71335030006 ndc11 (package): 71335030009 ndc11 (package): 71335030005 spl id: 80b8a53e-8bc2-4bd7-b002-a7736af37618 spl set id: 4b192084-dfdc-47bc-a968-6f49e137b248

Reported adverse events (FAERS/openFDA)#

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