basic care allergy relief

Manufacturer
Amazon.com Services LLC
Effective date
2020-11-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:33:07

Label at a glance#

Productbasic care allergy relief
Active ingredientLEVOCETIRIZINE DIHYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other respiratory allergies: • runny nose • itchy, watery eyes • sneezing • 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...

Storage and handling

• store between 20° and 25°C (68° and 77°F) • do not use if printed foil under cap is broken or missing

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

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
  • itchy, watery eyes
  • sneezing
  • 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

STORAGE AND HANDLING SECTION

  • store between 20° and 25°C (68° and 77°F)
  • do not use if printed foil under cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Original Prescription Strength

Compare to XYZAL® Allergy 24HR

active ingredient

Allergy Relief

Levocetirizine Dihydrochloride Tablets, 5 mg

Antihistamine

24 Hour Relief of:

Sneezing

Runny Nose

Itchy Nose or Throat

Itchy, Watery Eyes

actual size

80 TABLETS

allergy relief image
allergy relief image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN1
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD1
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY1

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
72288-241-27basic care allergy relief80 in 1 BOTTLETABLET, FILM COATED801
72288-241-27basic care allergy relief1 in 1 CARTONTABLET, FILM COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-241BASIC CARE ALLERGY RELIEF (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [AMAZON.COM SERVICES LLC]1Current NDC, Legacy NDC, 2 package rows20201106_fe965a15-7789-4ea5-b33e-2d3513409e1a.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
72288-24172288-241-27

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
A211983-001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28

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 22:38:342026-08A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-2884e616aacf4f…
2026-08-18 06:07:402026-07A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-283f01610625f2…
2019-09-15 20:21 UTC2019-09A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28f41ea6bd6efb…

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
basic care allergy reliefLEVOCETIRIZINE DIHYDROCHLORIDEAmazon.com Services LLCfe965a15-7789-4ea5-b33e-2d3513409e1a2020-11-02WarningsExact identifier
ndc (package): 72288-241-27
ndc (product): 72288-241
ndc11 (package): 72288024127
spl id: fe965a15-7789-4ea5-b33e-2d3513409e1a
spl set id: fe965a15-7789-4ea5-b33e-2d3513409e1a

Reported adverse events (FAERS/openFDA)#

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