Loratadine

Manufacturer
Preferred Pharmaceuticals Inc
Effective date
2026-05-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-06-03 18:03:33

Label at a glance#

ProductLoratadine
Active ingredientLORATADINE
Label structure14 sections

Indications and uses

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

Dosage and administration

 adults and children 6 years of age 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 

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet)

Loratadine, 10 mg USP

OTC - PURPOSE SECTION

Purpose

Antihistamine

Uses

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

Do not use if you ever have had an allergic reaction to this product or any of its ingredients.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

OTC - WHEN USING SECTION

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

OTC - STOP USE SECTION

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnanct or breast-feeding, 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.

Directions

DOSAGE & ADMINISTRATION SECTION

 adults and children 6 years of age 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

OTHER SAFETY INFORMATION

  • Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken.
  • Store between 20° - 25°C (68°-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients corn starch, lactose monohydrate, magnesium stearate, povidone

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-800-874-7464 Monday to Friday 9 AM to 5 PM EST

Repackaged By: Preferred Pharmaceuticals Inc.

NDC 68788-8616

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label

Loratadine Tablets 10mg
Loratadine Tablets 10mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311372loratadine 10 MG 24HR Oral TabletPSN4
311372loratadine 10 MG Oral TabletSCD4
311372loratadine 10 MG 24 HR Oral TabletSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 12823530-Count-Label.jpg
Data codeData Matrix**072325*30-Count-Label.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8616-0EA - Each68788-8616001303ac-af03-4a76-a5d8-515bcb2df1df12024-06-10
68788-8616-1EA - Each68788-86169b72fddd-9f0d-43e3-ab28-c4879cd9b75712024-06-10
68788-8616-3EA - Each68788-861619b73998-02ec-4d22-97d3-d06dbbcf5d3c12024-06-10
68788-8616-5EA - Each68788-8616a213f2c2-7457-49c9-b8b8-081f743016a312024-06-10
68788-8616-8EA - Each68788-8616c2cb649a-67b2-4b53-97d9-404786f9aec612024-07-12
68788-8616-9EA - Each68788-8616a2c217af-9bfe-4045-9709-c67d639d306b12024-06-10
16571-822-01EA - Each16571-8223d76a8ea-b185-45c7-a207-052dc7b85a6012022-04-06
16571-822-03EA - Each16571-822d04fcc31-5a7c-4519-ace4-930878ba9dad12022-04-06
16571-822-30EA - Each16571-82205b58fa0-a4a0-45a4-8ebc-e5d6ff043c9112022-04-06

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
68788-861668788-8616-0, 68788-8616-1, 68788-8616-5, 68788-8616-3, 68788-8616-9, 68788-8616-8
16571-822

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-07-23full-release2026-06-01 01:08:24

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
A214684-001LORATADINELORATADINE10MGTABLET / ORAL2021-01-07

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 22:38:342026-08A214684-001LORATADINE10MGTABLET / ORAL2021-01-0784e616aacf4f…
2026-08-18 06:07:402026-07A214684-001LORATADINE10MGTABLET / ORAL2021-01-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214684-001LORATADINE10MGTABLET / ORAL2021-01-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214684-001LORATADINE10MGTABLET / ORAL2021-01-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A214684-001LORATADINE10MGTABLET / ORAL2021-01-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214684-001LORATADINE10MGTABLET / ORAL2021-01-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214684-001LORATADINE10MGTABLET / ORAL2021-01-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214684-001LORATADINE10MGTABLET / ORAL2021-01-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214684-001LORATADINE10MGTABLET / ORAL2021-01-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214684-001LORATADINE10MGTABLET / ORAL2021-01-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214684-001LORATADINE10MGTABLET / ORAL2021-01-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214684-001LORATADINE10MGTABLET / ORAL2021-01-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214684-001LORATADINE10MGTABLET / ORAL2021-01-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214684-001LORATADINE10MGTABLET / ORAL2021-01-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214684-001LORATADINE10MGTABLET / ORAL2021-01-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214684-001LORATADINE10MGTABLET / ORAL2021-01-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214684-001LORATADINE10MGTABLET / ORAL2021-01-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214684-001LORATADINE10MGTABLET / ORAL2021-01-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214684-001LORATADINE10MGTABLET / ORAL2021-01-074b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214684-001LORATADINE10MGTABLET / ORAL2021-01-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214684-001LORATADINE10MGTABLET / ORAL2021-01-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A214684-001LORATADINE10MGTABLET / ORAL2021-01-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A214684-001LORATADINE10MGTABLET / ORAL2021-01-075aa47cf7b7d7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214684-001LORATADINE10MGTABLET / ORAL2021-01-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214684-001LORATADINE10MGTABLET / ORAL2021-01-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214684-001LORATADINE10MGTABLET / ORAL2021-01-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214684-001LORATADINE10MGTABLET / ORAL2021-01-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214684-001LORATADINE10MGTABLET / ORAL2021-01-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214684-001LORATADINE10MGTABLET / ORAL2021-01-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214684-001LORATADINE10MGTABLET / ORAL2021-01-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A214684-001LORATADINE10MGTABLET / ORAL2021-01-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A214684-001LORATADINE10MGTABLET / ORAL2021-01-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214684-001LORATADINE10MGTABLET / ORAL2021-01-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214684-001LORATADINE10MGTABLET / ORAL2021-01-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214684-001LORATADINE10MGTABLET / ORAL2021-01-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214684-001LORATADINE10MGTABLET / ORAL2021-01-07cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214684-001LORATADINE10MGTABLET / ORAL2021-01-07a50c72e98297…

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
LoratadineLORATADINEPreferred Pharmaceuticals Inc0a0d700d-bdba-4c90-a947-5d61d40ce4df2026-05-28WarningsExact identifier
ndc (package): 68788-8616-1
ndc (package): 68788-8616-8
ndc (package): 68788-8616-5
ndc (package): 68788-8616-3
ndc (package): 68788-8616-9
ndc (package): 68788-8616-0
ndc (product): 68788-8616
ndc11 (package): 68788861601
ndc11 (package): 68788861603
ndc11 (package): 68788861608
ndc11 (package): 68788861605
ndc11 (package): 68788861600
ndc11 (package): 68788861609
spl id: 8d420971-3031-42af-9fbb-22a99001f291
spl set id: 0a0d700d-bdba-4c90-a947-5d61d40ce4df
LoratadineLORATADINERising Pharmaceuticals, Incd28128a3-af54-440e-9bd4-0fccf393d18a2022-03-10WarningsExact identifier
ndc (product): 16571-822

Reported adverse events (FAERS/openFDA)#

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