Perrigo Loratadine Tablets, 10 mg Drug Facts

Manufacturer
A-S Medication Solutions
Effective date
2025-12-06
Label type
HUMAN OTC DRUG LABEL
Version
23
Source
full-release
Hydrated at
2026-06-01 01:20:12

Label at a glance#

ProductLoratadine antihistamine
Active ingredientLORATADINE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat

Dosage and administration

adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine 10 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper 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 ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product

OTC - WHEN USING SECTION

do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 and children 6 years and over

1 tablet daily; not more than 1 tablet in 24 hours

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-0836

NDC: 50090-0836-0 10 TABLET in a BOTTLE

NDC: 50090-0836-4 30 TABLET in a BOTTLE

NDC: 50090-0836-5 90 TABLET in a BOTTLE

Loratadine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311372loratadine 10 MG 24HR Oral TabletPSN23
311372loratadine 10 MG Oral TabletSCD23
311372loratadine 10 MG 24 HR Oral TabletSY23

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00350090083644(17)991231(10)9987654(21)AA000000GTIN-14: 00350090083644
GTIN-12: 350090083644
UPC-A: 350090083644
EAN-13: 0350090083644
GTIN storage (14 digits): 00350090083644
lbl500900836.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0836-0Loratadineantihistamine10 in 1 BOTTLETABLET1023
50090-0836-1Loratadineantihistamine20 in 1 BOTTLETABLET2023
50090-0836-3Loratadineantihistamine15 in 1 BOTTLETABLET1523
50090-0836-4Loratadineantihistamine30 in 1 BOTTLETABLET3023
50090-0836-5Loratadineantihistamine90 in 1 BOTTLETABLET9023
50090-0836-6Loratadineantihistamine7 in 1 BOTTLETABLET723

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0836-0EA - Each50090-08364b7ec55d-080f-433c-86cc-a5cef28b20f812018-10-11
50090-0836-1EA - Each50090-0836abf7202f-d897-4f2c-972a-c7248b4e49b712018-10-11
50090-0836-3EA - Each50090-08362c00fa1f-536f-402f-a228-3224eab7077a12018-10-11
50090-0836-4EA - Each50090-08365c3a43ed-c0ad-465b-9c88-e55e7224794e12018-10-11
50090-0836-5EA - Each50090-083624327a74-a93f-4d1a-87be-a3aa9958819912018-10-11
50090-0836-6EA - Each50090-083641b53fb0-ef89-45fd-befd-867fc961c44a12018-10-11
45802-650-65EA - Each45802-6502be54e45-0384-4ce9-95be-a3d9c2d051b912012-07-24
45802-650-78EA - Each45802-6509595d39f-57b3-4c72-a349-5e7bf613881b12012-07-24
45802-650-87EA - Each45802-650a7cf4204-74e4-4e42-b2ff-961de1024e5e12012-07-24

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-083650090-0836-0, 50090-0836-5, 50090-0836-1, 50090-0836-3, 50090-0836-6, 50090-0836-4
45802-650

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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 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
A076301-001LORATADINELORATADINE10MGTABLET / ORAL2004-06-25

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 13:18:302026-09A076301-001LORATADINE10MGTABLET / ORAL2004-06-25c2088c7a36db…
2026-09-14 22:38:342026-08A076301-001LORATADINE10MGTABLET / ORAL2004-06-2584e616aacf4f…
2026-08-18 06:07:402026-07A076301-001LORATADINE10MGTABLET / ORAL2004-06-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076301-001LORATADINE10MGTABLET / ORAL2004-06-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A076301-001LORATADINE10MGTABLET / ORAL2004-06-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076301-001LORATADINE10MGTABLET / ORAL2004-06-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076301-001LORATADINE10MGTABLET / ORAL2004-06-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076301-001LORATADINE10MGTABLET / ORAL2004-06-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076301-001LORATADINE10MGTABLET / ORAL2004-06-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076301-001LORATADINE10MGTABLET / ORAL2004-06-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076301-001LORATADINE10MGTABLET / ORAL2004-06-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076301-001LORATADINE10MGTABLET / ORAL2004-06-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076301-001LORATADINE10MGTABLET / ORAL2004-06-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076301-001LORATADINE10MGTABLET / ORAL2004-06-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076301-001LORATADINE10MGTABLET / ORAL2004-06-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076301-001LORATADINE10MGTABLET / ORAL2004-06-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076301-001LORATADINE10MGTABLET / ORAL2004-06-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076301-001LORATADINE10MGTABLET / ORAL2004-06-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076301-001LORATADINE10MGTABLET / ORAL2004-06-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076301-001LORATADINE10MGTABLET / ORAL2004-06-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A076301-001LORATADINE10MGTABLET / ORAL2004-06-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076301-001LORATADINE10MGTABLET / ORAL2004-06-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-253f01610625f2…
2019-09-15 20:21 UTC2019-09A076301-001LORATADINE10MGTABLET / ORAL2004-06-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A076301-001LORATADINE10MGTABLET / ORAL2004-06-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076301-001LORATADINE10MGTABLET / ORAL2004-06-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076301-001LORATADINE10MGTABLET / ORAL2004-06-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076301-001LORATADINE10MGTABLET / ORAL2004-06-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076301-001LORATADINE10MGTABLET / ORAL2004-06-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076301-001LORATADINE10MGTABLET / ORAL2004-06-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076301-001LORATADINE10MGTABLET / ORAL2004-06-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A076301-001LORATADINE10MGTABLET / ORAL2004-06-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A076301-001LORATADINE10MGTABLET / ORAL2004-06-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076301-001LORATADINE10MGTABLET / ORAL2004-06-253a93d1ddd44b…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loratadine antihistamineLORATADINEA-S Medication Solutions1203981a-becd-4854-810d-b6d8842b5bd22025-12-06WarningsExact identifier
ndc (package): 50090-0836-3
ndc (package): 50090-0836-4
ndc (package): 50090-0836-0
ndc (package): 50090-0836-5
ndc (package): 50090-0836-6
ndc (package): 50090-0836-1
ndc (product): 50090-0836
ndc11 (package): 50090083600
ndc11 (package): 50090083605
ndc11 (package): 50090083603
ndc11 (package): 50090083604
ndc11 (package): 50090083606
ndc11 (package): 50090083601
spl id: 30a2cbb3-9526-43e3-95a7-cec6f4019e5d
spl set id: 1203981a-becd-4854-810d-b6d8842b5bd2
Loratadine antihistamineLORATADINEPadagis Israel Pharmaceuticals Ltdc72d8a30-520e-4d25-8f02-0c891e070a1a2025-09-12WarningsExact identifier
ndc (product): 45802-650

Reported adverse events (FAERS/openFDA)#

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