FDA.reportPublic FDA data

24HR Allergy Relief

Manufacturer
LEADER/ Cardinal Health 110, Inc.
Effective date
2026-01-20
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:33:55

Label at a glance#

Product24HR Allergy Relief
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...

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

LEADER

NDC 70000-0362-2

Original Prescription Strength

24HR Allergy Relief
Levocetirizine Dihydrochloride
Tablets USP, 5 mg I Antihistamine

24 Hour Relief of

Sneezing, Runny Nose
Itchy Nose or Throat, and
Itchy, Watery Eyes

COMPARE TO XYZAL®
ALLERGY 24HR
active ingredient*

100% Money
Back Guarantee

35 TABLETS

cartoncarton

Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER

NDC 70000-0362-2

Original Prescription Strength

24HR Allergy Relief
Levocetirizine Dihydrochloride
Tablets USP, 5 mg I Antihistamine

24 Hour

35 TABLETS

ConatinerConatiner

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN9
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD9
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY9

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0362-124HR Allergy Relief2 in 1 CARTONTABLET, COATED29
70000-0362-124HR Allergy Relief5 in 1 BLISTER PACKTABLET, COATED59
70000-0362-224HR Allergy Relief35 in 1 BOTTLETABLET, COATED359
70000-0362-224HR Allergy Relief1 in 1 CARTONTABLET, COATED19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0362-1EA - Each70000-0362ae14f336-8149-4244-9692-04f6e97785ae12018-11-06
70000-0362-2EA - Each70000-03627278aaf7-6470-4207-88e6-01c13971865612018-07-03
43598-735-30EA - Each43598-735f63cfcf2-4da8-499a-bfc3-df6f91d40e0512024-09-09
43598-735-90EA - Each43598-7359046de29-e000-4f9e-a13e-a7b3f0a9265812024-09-09

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-036270000-0362-2, 70000-0362-1
43598-735

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
levocetirizine dihydrochlorideSOD6A38AGAACTIB
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSES3NXW29V3WOIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
Polyethylene Glycol, Unspecified3WJQ0SDW1AIACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-12-10monthly-update2026-06-03 17:45:44

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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210375-001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19c2088c7a36db…
2026-09-14 22:38:342026-08A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-1984e616aacf4f…
2026-08-18 06:07:402026-07A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-193f01610625f2…
2019-09-15 20:21 UTC2019-09A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-193a93d1ddd44b…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEDr. Reddy's Laboratories Inc.1f722b84-08de-7e6a-41ac-2c9d9bb9fb432026-06-04WarningsExact identifier
ndc (product): 43598-735
24HR Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDELEADER/ Cardinal Health 110, Inc.6ba57f12-fd25-c4a6-ff2d-2955116f84c42026-01-20WarningsExact identifier
ndc (package): 70000-0362-2
ndc (package): 70000-0362-1
ndc (product): 70000-0362
ndc11 (package): 70000036202
ndc11 (package): 70000036201
spl id: e888ebac-b741-9f96-5cd8-edfbad1a721d
spl set id: 6ba57f12-fd25-c4a6-ff2d-2955116f84c4

Reported adverse events (FAERS/openFDA)#

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