Levocetirzine Dihydrochloride Tablets USP, 5 mg

Manufacturer: Walgreens Company
Effective date: 2019-12-11
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: legacy-cache
Hydrated at: 2026-08-01 21:22:58

Label at a glance#

Productlevocetirizine dihydrochloride

Active ingredientlevocetirizine dihydrochloride

Label structure11 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Dosage and administration

adults 65 years of age and older ask a doctor adults and children 12-64 years of age take 1 tablet (5 mg) once daily in the evening do not take more than 1 tablet (5 mg) in 24 hours 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms children 6-11 years of age take 1/2 tablet (2.5 mg) once daily in the evening do not take more than 1/2 tablet (2.5 mg) in 24 hours children unde...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-375-3784

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Levocetirizine dihydrochloride USP, 5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other 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 kidney disease
if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

ever had trouble urinating or emptying your bladder

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 doctor if

OTC - STOP USE SECTION

you have trouble urinating or emptying your bladder
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-feding: 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 65 years of age and older	ask a doctor
adults and children 12-64 years of age	take 1 tablet (5 mg) once daily in the evening do not take more than 1 tablet (5 mg) in 24 hours 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6-11 years of age	take 1/2 tablet (2.5 mg) once daily in the evening do not take more than 1/2 tablet (2.5 mg) in 24 hours
children under 6 years of age	do not use
consumers with kidney disease	do not use

Other information

SPL UNCLASSIFIED SECTION

store between 20° and 25°C (68° and 77°F)
(bottles only) safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing
(blister only) safety sealed: do not use if seal is broken or if individual blister unit is open or torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-375-3784

Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORIGINAL PRESCRIPTION STRENGTH
Compare to Xyzal^®Allergy 24HR active ingredient^‡‡

0363-5528-35

NEW Well at Walgreens
WALGREENS PHARMACIST RECOMMENDED^‡

ORIGINAL
PRESCRIPTION
STRENGTH

Levocetirizine
24-Hour Allergy

Levocetirizine Dihydrochloride
Tablets, 5 mg / Antihistamine

Relief of:

Sneezing
Runny nose
Itchy nose or throat
Itchy, watery eyes

24 HOUR

35 TABLETS

carton

Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Well at Walgreens

NDC 0363-5528-35

ORIGINAL
PRESCRIPTION STRENGTH

Levocetirizine
24-Hour Allergy

Levocetirizine Dihydrochloride
Tablets, 5 mg / Antihistamine

35 TABLETS

bottle

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0363-5528-10	2025-12-10	C162847	48780-1	2cef2736-9730-d83d-e063-dadaa90ab31f	Levocetirzine Dihydrochloride Tablets USP, 5 mg
0363-5528-35	2025-12-10	C162847	48780-1	2cef2736-9730-d83d-e063-dadaa90ab31f	Levocetirzine Dihydrochloride Tablets USP, 5 mg
0363-5528-55	2025-12-10	C162847	48780-1	2cef2736-9730-d83d-e063-dadaa90ab31f	Levocetirzine Dihydrochloride Tablets USP, 5 mg
0363-5528-80	2025-12-10	C162847	48780-1	2cef2736-9730-d83d-e063-dadaa90ab31f	Levocetirzine Dihydrochloride Tablets USP, 5 mg
0363-5528-10	2025-01-30	C162847	48780-1	2cef2736-9730-d83d-e063-dadaa90ab31f	Levocetirzine Dihydrochloride Tablets USP, 5 mg
0363-5528-35	2025-01-30	C162847	48780-1	2cef2736-9730-d83d-e063-dadaa90ab31f	Levocetirzine Dihydrochloride Tablets USP, 5 mg
0363-5528-55	2025-01-30	C162847	48780-1	2cef2736-9730-d83d-e063-dadaa90ab31f	Levocetirzine Dihydrochloride Tablets USP, 5 mg
0363-5528-80	2025-01-30	C162847	48780-1	2cef2736-9730-d83d-e063-dadaa90ab31f	Levocetirzine Dihydrochloride Tablets USP, 5 mg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-5528	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [WALGREENS COMPANY]	6	Legacy NDC	20231031_acfb0252-28ae-3f02-3657-3517a099054e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0363-5528-80	EA - Each	0363-5528	7e36e7d1-ba07-4332-a28a-a61dbe5ff483	1	2022-06-06

Products#

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

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

levocetirizine dihydrochloride
levocetirizine
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSES
TITANIUM DIOXIDE
Polyethylene Glycol, Unspecified

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0363-5528	0363-5528-35, 0363-5528-55, 0363-5528-80, 0363-5528-10

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
levocetirizine dihydrochloride	SOD6A38AGA	ACTIB
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
Polyethylene Glycol, Unspecified	3WJQ0SDW1A	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL			2018-01-19

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 2 · 43 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	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`f41ea6bd6efb…`

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
1a164f7e-6030-d6aa-6210-b83cdefd6895			acfb0252-28ae-3f02-3657-3517a099054e	2019-12-11	Warnings	Exact identifier spl set id: acfb0252-28ae-3f02-3657-3517a099054e

Reported adverse events (FAERS/openFDA)#

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