FDA.reportPublic FDA data

Allergy Relief

Manufacturer
Topco Associates, LLC
Effective date
2026-09-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-29 01:02:42

Label at a glance#

ProductAllergy Relief
Active ingredientLEVOCETIRIZINE DIHYDROCHLORIDE
Label structure10 sections

Dosage and administration

adults 65 years of age and older • ask a doctor adults and children 12 to 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 to 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 c...

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Levocetirizine dihydrochloride USP 5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Use

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

OTC - DO NOT USE SECTION

Do not use

• 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have
• ever had trouble urinating or emptying your bladder

OTC - WHEN USING SECTION

When using this product
• drowsiness may occur • avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

Stop use and ask a doctor if
• you have trouble urinating or emptying your bladder
• an allergic reaction to this product occurs.
Seek medical help right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding
• if breast-feeding: not recommended
• if pregnant: ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children
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 to 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 to 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

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide.

Questions or Comments?

OTC - QUESTIONS SECTION

call 1-800-373-6981

SPL UNCLASSIFIED SECTION

Distributed by:

TOPCO ASSOCIATES LLC

Itasca, IL 60143

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Allergy Relief
Levocetirizine Dihydrochloride Tablets USP, 5 mg

Carton 35 Ct.

Levocetirizine 35 ct CartonLevocetirizine 35 ct Carton

Label 35 ct.

Levocetirizine 35 ct LabelLevocetirizine 35 ct Label

Carton 80 Ct.

Levocetirizine 80 ct CartonLevocetirizine 80 ct Carton

Label 80 Ct.

Levocetirizine 80 ct LabelLevocetirizine 80 ct Label

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-91576162-915-35, 76162-915-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
LEVOCETIRIZINE DIHYDROCHLORIDESOD6A38AGAACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
HYPROMELLOSES3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYSORBATE 806OZP39ZG8HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
A213513-001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-2984e616aacf4f…
2026-08-18 06:07:402026-07A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-294b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29a50c72e98297…

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 17 · 323 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefCETIRIZINE HYDROCHLORIDELIDL US LLCe5fd935d-5b60-7270-e053-2995a90a71412026-09-09WarningsName fallback
brand name: Allergy Relief
LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDEGlenmark Pharmaceuticals Inc., USA60ae7e0e-281c-40a3-a0d3-259b843ddaaa2026-09-09Warnings, Adverse reactionsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Allergy ReliefCHLORPHENIRAMINE MALEATEWALMART INC.5e6623c3-6210-4c50-94d6-5554f36876d12026-08-31WarningsName fallback
brand name: Allergy Relief
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP, LLC69af44c2-390c-4223-889a-d5555aef57782026-08-28WarningsName fallback
brand name: Allergy Relief
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAmazon.com Services LLC298e9164-e378-4b39-a944-bfc8f8baa4de2026-08-27WarningsName fallback
brand name: Allergy Relief
Allergy ReliefCETIRIZINE HCLCVS PHARMACY, INCfb850a4c-7ac1-4993-b6ea-5c8d42e177032026-08-26WarningsName fallback
brand name: Allergy Relief
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Incc88e93d4-66b6-4327-b9e5-0e0a95a18d662026-08-25WarningsName fallback
brand name: Allergy Relief
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company7d972559-6184-476b-9cbf-1bc5663ea00d2026-08-24WarningsName fallback
brand name: Allergy Relief
allergy reliefCETIRIZINE HYDROCHLORIDEWalgreen Company678dcc09-55da-4d9d-a39a-c450c61c387b2026-08-18WarningsName fallback
brand name: allergy relief
Allergy ReliefFEXOFENADINE HCLSafeway, Inc.a29e33ac-77f7-4e06-b6f1-82ecaa919cad2026-08-17WarningsName fallback
brand name: Allergy Relief
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEGolden State Medical Supply, Inc.163dcce7-4535-a596-e063-6394a90a634f2026-08-13Warnings, Adverse reactionsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
ALLERGY RELIEFLEVOCETIRIZINE DIHYDROCHLORIDEAmazon.com Services LLC9ba39415-34af-49ca-b5cb-464e755179172026-08-12WarningsName fallback
brand name: ALLERGY RELIEF
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Inc150b68ba-3ed4-4533-9118-74e76eaf6e482026-08-04WarningsName fallback
brand name: Allergy Relief
Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationce393bff-498b-42e6-a41c-bbfbc58fb42c2026-08-04WarningsName fallback
brand name: Allergy Relief
Allergy ReliefDIPHENHYDRAMINE HCLCVS PHARMACYe958eef1-8aae-4365-ac64-95a9e8e7e0f22026-07-27WarningsName fallback
brand name: Allergy Relief
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP INC38400854-27fa-e291-e063-6294a90a5c4e2026-07-27WarningsName fallback
brand name: Allergy Relief
Allergy ReliefDIPHENHYDRAMINE HCLBetter Living Brands, LLC65802aa7-64e7-4435-ad6b-65895fba17ce2026-07-27WarningsName fallback
brand name: Allergy Relief
allergy reliefLORATADINEWalgreen Company41f8fc1d-2d14-48da-a233-23e9c11296d92026-07-23WarningsName fallback
brand name: allergy relief
Allergy ReliefFEXOFENADINE HCLP & L Development, LLC35b807b5-2e7a-446b-b378-eb5391ddfd142026-07-22WarningsName fallback
brand name: Allergy Relief
Allergy ReliefFEXOFENADINE HYDROCHLORIDEKroger Company2718d6a2-0678-4703-9a5a-26b27d7539422026-07-20WarningsName fallback
brand name: Allergy Relief

Reported adverse events (FAERS/openFDA)#

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