Goodmeds Levocetirizine Dihydrochloride 5mg 365 count - Cabinet Health P.B.C.

Manufacturer
Cabinet Health P.B.C.
Effective date
2026-09-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-10-06 02:04:43

Label at a glance#

ProductGoodmeds Levocetirizine Dihydrochloride 5mg 365 count
Active ingredientLEVOCETIRIZINE DIHYDROCHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)
Levocetirizine HCl 5 mg

OTC - PURPOSE SECTION

Purpose
Antihistamine

INDICATIONS & USAGE SECTION

Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory
allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

WARNINGS SECTION

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

Stop use and ask a doctor if
have trouble urinating or emptying your bladder

an allergic reaction to this product occurs. Seek medical help right away.

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)

DOSAGE & ADMINISTRATION SECTION

Directions

adults 65 years and over:

  • ask a doctor

adults and children 12-64 years of age:

  • take 1 tablet (5mg) once daily in the evening
  • do not take more than 1 tablet (5mg) in 24 hours
  • 1./2 tablet (2.5mg) once daily in the evening may be appropriate for less severe symptoms

children 6-11 years of age:

  • take ½ tablet (2.5mg) once daily in the evening
  • do not take more than ½ tablet (2.5mg) in 24 hours

Children under 6 years of age:

  • Do not use


Consumers with liver or kidney disease:

  • do not use

OTHER SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT SECTION

Hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, silicon dioxide, titanium dioxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Questions or comments?

Call 1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM EST

Label:

Label ImageLabel Image

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82725-405182725-4051-1, 82725-4051-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-06-23monthly-update2026-07-17 21:37:15

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Goodmeds Levocetirizine Dihydrochloride 5mg 365 countLEVOCETIRIZINE DIHYDROCHLORIDE 5MGCabinet Health P.B.C.54f34304-952e-2f07-e063-6394a90a80ee2026-06-23WarningsExact identifier
ndc (package): 82725-4051-1
ndc (product): 82725-4051
ndc11 (package): 82725405101
spl set id: 54f34304-952e-2f07-e063-6394a90a80ee

Reported adverse events (FAERS/openFDA)#

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