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#
Contacts and useful links#
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:
Products#
Every source-derived product name is available through these pages.
- Goodmeds Levocetirizine Dihydrochloride 5mg 365 count
- Levocetirizine Dihydrochloride 5mg
- LEVOCETIRIZINE DIHYDROCHLORIDE
- LEVOCETIRIZINE
- HYPROMELLOSE 2910 (3 MPA.S)
- POLYETHYLENE GLYCOL 400
- LACTOSE MONOHYDRATE
- TITANIUM DIOXIDE
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYSORBATE 80
- SILICON DIOXIDE
- HYPROMELLOSE 2910 (6 MPA.S)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82725-4051 | 82725-4051-1, 82725-4051-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2026-06-23 | monthly-update | 2026-07-17 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 products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | c0c555d07b60… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | a50c72e98297… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Goodmeds Levocetirizine Dihydrochloride 5mg 365 count | LEVOCETIRIZINE DIHYDROCHLORIDE 5MG | Cabinet Health P.B.C. | 54f34304-952e-2f07-e063-6394a90a80ee | 2026-06-23 | Warnings | 82725-4051-1 82725-4051 82725405101 54f34304-952e-2f07-e063-6394a90a80ee |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
