Cetirizine Hydrochloride Tablets

Manufacturer: Strategic Sourcing Services LLC
Effective date: 2024-10-23
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 20:51:15

Label at a glance#

Productcetirizine hydrochloride

Active ingredientCETIRIZINE HYDROCHLORIDE

Label structure12 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 contact1-888-375-3784

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

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

OTC - ASK DOCTOR SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistaminecontaining hydroxyzine.

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

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 if

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.

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

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

Questions?

OTC - QUESTIONS SECTION

call 1-888-375-3784.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 ct Carton

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 ct Container label

30 ct Container

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62011-0414	CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [STRATEGIC SOURCING SERVICES LLC]	5	Legacy NDC	20241025_00b01fa8-2533-ff93-bd13-ca472c46bb94.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62011-0414-1	EA - Each	62011-0414	ddf0f908-7456-4e65-b163-aa5157cbedb5	1	2021-06-02

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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62011-0414	62011-0414-1, 62011-0414-2, 62011-0414-3

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
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

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	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 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2008-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2008-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2008-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2008-01-15	`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
69496856-286b-794b-edde-004aac068469			00b01fa8-2533-ff93-bd13-ca472c46bb94	2025-07-16	Warnings	Exact identifier spl set id: 00b01fa8-2533-ff93-bd13-ca472c46bb94

Reported adverse events (FAERS/openFDA)#

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