FDA.reportPublic FDA data

Levocetirizine Dihydrochloride

Manufacturer
Micro Labs Limited | InvaTech Pharma Solutions LLC
Effective date
2025-02-16
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:55:33

Label at a glance#

ProductLevocetirizine Dihydrochloride
Active ingredientLEVOCETIRIZINE DIHYDROCHLORIDE
Label structure10 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 than1 tablet (5 mg) in 24 hours ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms children 6-11 years of age take ½ tablet (2.5 mg) once daily in the evening do not take more than ½ tablet (2.5 mg) in 24 hours children under 6 y...

Storage and handling

store between 20° and 25°C (68° and 77°F) safety sealed: do not use if carton was opened or torn

Label contents#

Full prescribing information#

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 a 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-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).

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

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 than1 tablet (5 mg) in 24 hours
  • ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6-11 years of age
  • take ½ tablet (2.5 mg) once daily in the evening
  • do not take more than ½ tablet (2.5 mg) in 24 hours
children under 6 years of age
  • do not use
consumers with kidney disease
  • do not use


STORAGE

STORAGE AND HANDLING SECTION

  • store between 20° and 25°C (68° and 77°F)
  • safety sealed: do not use if carton was opened or torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, silicon dioxide, and titanium dioxide

Questions or comments?

SPL UNCLASSIFIED SECTION

call 1-855-839-8195



PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


MICRO LABS LIMITED
Container

NDC- 42571-312-90
Levocetirizine dihydrochloride Tablets USP
5mg
Antihistamine

90 Tablets    MICRO LABS
micro container labelmicro container label
Container-Carton



NDC- 42571-312-90
Levocetirizine dihydrochloride Tablets USP
5mg
Antihistamine

90 Tablets    MICRO LABS
micro carton labelmicro carton label

INVATECH PHARMA SOLUTIONS LLC
Container




NDC- 42571-312-90
Levocetirizine dihydrochloride Tablets USP
5mg
Antihistamine

90 Tablets    MICRO LABS
invatech container labelinvatech container label
Container-Carton



NDC- 42571-312-90
Levocetirizine dihydrochloride Tablets USP
5mg
Antihistamine

90 Tablets    MICRO LABS
invatech carton labelinvatech carton label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN6
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD6
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LEVOCETIRIZINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760Product name720190702

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42571-312-112025-02-17C16284748780-12cef2736-ab1e-d83d-e063-dadaa90ab31fDrug Facts
42571-312-182025-02-17C16284748780-12cef2736-ab1e-d83d-e063-dadaa90ab31fDrug Facts
42571-312-532025-02-17C16284748780-12cef2736-ab1e-d83d-e063-dadaa90ab31fDrug Facts
42571-312-902025-02-17C16284748780-12cef2736-ab1e-d83d-e063-dadaa90ab31fDrug Facts
42571-312-112025-01-30C16284748780-12cef2736-ab1e-d83d-e063-dadaa90ab31fDrug Facts
42571-312-182025-01-30C16284748780-12cef2736-ab1e-d83d-e063-dadaa90ab31fDrug Facts
42571-312-532025-01-30C16284748780-12cef2736-ab1e-d83d-e063-dadaa90ab31fDrug Facts
42571-312-902025-01-30C16284748780-12cef2736-ab1e-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-312-11Levocetirizine Dihydrochloride100 in 1 CARTONTABLET1006
42571-312-18Levocetirizine Dihydrochloride1 in 1 CARTONTABLET16
42571-312-18Levocetirizine Dihydrochloride10 in 1 BOTTLETABLET106
42571-312-32Levocetirizine Dihydrochloride10 in 1 BLISTER PACKTABLET106
42571-312-53Levocetirizine Dihydrochloride2500 in 1 POUCHTABLET25006
42571-312-90Levocetirizine Dihydrochloride90 in 1 BOTTLETABLET906
42571-312-90Levocetirizine Dihydrochloride1 in 1 CARTONTABLET16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-312LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET [MICRO LABS LIMITED]6Current NDC, Legacy NDC, 7 package rows20250221_78ff8e86-ee5b-4626-aa81-49e974febf1d.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42571-31242571-312-53, 42571-312-90, 42571-312-32, 42571-312-11, 42571-312-18

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
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
LEVOCETIRIZINE DIHYDROCHLORIDESOD6A38AGAACTIB

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211551-001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-2084e616aacf4f…
2026-08-18 06:07:402026-07A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-203f01610625f2…
2019-09-15 20:21 UTC2019-09A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20f41ea6bd6efb…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEMicro Labs Limited78ff8e86-ee5b-4626-aa81-49e974febf1d2025-02-16WarningsExact identifier
ndc (package): 42571-312-18
ndc (package): 42571-312-32
ndc (package): 42571-312-53
ndc (package): 42571-312-11
ndc (package): 42571-312-90
ndc (product): 42571-312
ndc11 (package): 42571031253
ndc11 (package): 42571031290
ndc11 (package): 42571031218
ndc11 (package): 42571031211
ndc11 (package): 42571031232
spl id: 2e504864-a08d-48e1-e063-6394a90a92ed
spl set id: 78ff8e86-ee5b-4626-aa81-49e974febf1d

Reported adverse events (FAERS/openFDA)#

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