FDA.reportPublic FDA data

Xyzal Allergy 24HR

Manufacturer
Chattem, Inc.
Effective date
2026-03-11
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 01:49:20

Label at a glance#

ProductXyzal Allergy 24HR
Active ingredientLEVOCETIRIZINE DIHYDROCHLORIDE
Label structure12 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 ■ 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 childre...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Xyzal Allergy 24HR Tablet

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Levocetirizine dihydrochloride 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).

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
■ 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

Other information

SPL UNCLASSIFIED SECTION

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

(if bottled) safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing

(if stretch card) safety sealed: do not use if sealed package was torn or opened, or if printed foil inner seal on bottle is torn or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal anhydrous silica, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800- 633-1610

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORIGINAL
PRESCIPTION STRENGTH
XYZAL
ALLERGY 24HR
5 mg/ antihistamine
10 Tablets

ORIGINAL PRESCIPTION STRENGTH XYZAL ALLERGY 24HR 5 mg/ antihistamine 10 TabletsORIGINAL PRESCIPTION STRENGTH XYZAL ALLERGY 24HR 5 mg/ antihistamine 10 Tablets

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41167-3510-1
XYZAL
Allergy 24HR
5 mg
35 Tablets

NDC 41167-3510-1 XYZAL Allergy 24HR 5 mg 35 TabletsNDC 41167-3510-1 XYZAL Allergy 24HR 5 mg 35 Tablets

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41167-3511-2
XYZAL
Allergy 24HR
5 mg
20 Tablets

PRINCIPAL DISPLAY PANEL NDC 41167-3511-2 XYZAL Allergy 24HR 5 mg 20 TabletsPRINCIPAL DISPLAY PANEL NDC 41167-3511-2 XYZAL Allergy 24HR 5 mg 20 Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN14
855174Xyzal 5 MG 24HR Oral TabletPSN14
855174levocetirizine dihydrochloride 5 MG Oral Tablet [Xyzal]SBD14
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD14
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY14
855174Xyzal 5 MG 24 HR Oral TabletSY14

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
41167-3510-0Xyzal Allergy 24HR1 in 1 CARTONTABLET114
41167-3510-0Xyzal Allergy 24HR10 in 1 BLISTER PACKTABLET1014
41167-3510-1Xyzal Allergy 24HR35 in 1 BOTTLETABLET3514
41167-3510-1Xyzal Allergy 24HR1 in 1 CARTONTABLET114
41167-3510-2Xyzal Allergy 24HR1 in 1 CARTONTABLET114
41167-3510-2Xyzal Allergy 24HR55 in 1 BOTTLETABLET5514
41167-3510-3Xyzal Allergy 24HR80 in 1 BOTTLETABLET8014
41167-3510-3Xyzal Allergy 24HR1 in 1 CARTONTABLET114
41167-3510-4Xyzal Allergy 24HR2 in 1 CARTONTABLET214
41167-3510-4Xyzal Allergy 24HR55 in 1 BOTTLETABLET5514
41167-3510-5Xyzal Allergy 24HR1 in 1 CARTONTABLET114
41167-3510-5Xyzal Allergy 24HR45 in 1 BOTTLETABLET4514
41167-3510-6Xyzal Allergy 24HR5 in 1 BLISTER PACKTABLET514
41167-3510-6Xyzal Allergy 24HR1 in 1 CARTONTABLET114
41167-3511-2Xyzal Allergy 24HR1 in 1 CARTONTABLET114
41167-3511-2Xyzal Allergy 24HR20 in 1 BLISTER PACKTABLET2014
41167-3511-8Xyzal Allergy 24HR40 in 1 BLISTER PACKTABLET4014
41167-3511-8Xyzal Allergy 24HR1 in 1 CARTONTABLET114
41167-3511-9Xyzal Allergy 24HR1 in 1 CARTONTABLET114
41167-3511-9Xyzal Allergy 24HR60 in 1 BLISTER PACKTABLET6014
41167-3513-4Xyzal Allergy 24HR90 in 1 BLISTER PACKTABLET9014
41167-3513-4Xyzal Allergy 24HR1 in 1 CARTONTABLET114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-3510-0EA - Each41167-3510ed422210-66a2-43a7-a74f-170d7fd559a312017-04-05
41167-3510-1EA - Each41167-3510c4714fa6-0acb-47c4-9e49-3b7987d1ffa812017-04-05
41167-3510-2EA - Each41167-3510a4d33942-1af5-49ae-b610-a78020abde8212017-04-05
41167-3510-3EA - Each41167-351012df48b0-057c-414c-b5cf-92d286777a4f12017-04-05

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
41167-351041167-3510-0, 41167-3510-1, 41167-3510-2, 41167-3510-3, 41167-3510-4, 41167-3510-5, 41167-3510-6
41167-351141167-3511-2, 41167-3511-8, 41167-3511-9
41167-351341167-3513-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
LEVOCETIRIZINE DIHYDROCHLORIDESOD6A38AGAACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
HYPROMELLOSES3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
LEVOCETIRIZINE DIHYDROCHLORIDESOD6A38AGAACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
HYPROMELLOSES3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
LEVOCETIRIZINE DIHYDROCHLORIDESOD6A38AGAACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
HYPROMELLOSES3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
132026-02-04legacy-cache2026-10-21 11:48:40

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
N209089-001XYZAL ALLERGY 24HRLEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALRLD, RS2017-01-31

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 13:18:302026-09N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-31c2088c7a36db…
2026-09-14 22:38:342026-08N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-3184e616aacf4f…
2026-08-18 06:07:402026-07N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-3187673890dc5c…
2021-03-12 10:30 UTC2021-03N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-313f01610625f2…
2019-09-15 20:21 UTC2019-09N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-31b00525d2431f…
2019-07-19 19:46 UTC2019-07N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-313f0d92c62455…
2023-05-13 08:27 UTC2023-05N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-31053a50430f4f…
2023-01-26 05:58 UTC2023-01N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N209089-001XYZAL ALLERGY 24HR5MGTABLET / ORALRLD, RS2017-01-313a93d1ddd44b…

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
Xyzal Allergy 24HRLEVOCETIRIZINE DIHYDROCHLORIDEChattem, Inc.8be45c2a-1eca-4a00-81b9-f7babdbdcd412026-03-11WarningsExact identifier
ndc (package): 41167-3510-1
ndc (package): 41167-3510-5
ndc (package): 41167-3510-0
ndc (package): 41167-3510-3
ndc (package): 41167-3511-9
ndc (package): 41167-3513-4
ndc (package): 41167-3510-4
ndc (package): 41167-3510-2
ndc (package): 41167-3511-2
ndc (package): 41167-3510-6
ndc (package): 41167-3511-8
ndc (product): 41167-3511
ndc (product): 41167-3513
ndc (product): 41167-3510
ndc11 (package): 41167351102
ndc11 (package): 41167351000
ndc11 (package): 41167351108
ndc11 (package): 41167351004
ndc11 (package): 41167351304
ndc11 (package): 41167351109
ndc11 (package): 41167351003
ndc11 (package): 41167351005
ndc11 (package): 41167351002
ndc11 (package): 41167351006
ndc11 (package): 41167351001
spl id: f43bc46c-c507-4ccf-9b93-17eaeebf4ed5
spl set id: 8be45c2a-1eca-4a00-81b9-f7babdbdcd41

Reported adverse events (FAERS/openFDA)#

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