Allergy Relief

Manufacturer
First Aid Direct
Effective date
2019-09-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:10:11

Label at a glance#

ProductAllergy Relief
Active ingredientLORATADINE
Label structure8 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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Loratadine 10mg

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

OTC - STOP USE SECTION

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

Pregnancy/Breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately.

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

SPL UNCLASSIFIED SECTION

  • store between 20° to 25°C (68° to 77°F)
  • protect from excessive moisture
  • do not use if blister unit is torn or open

Inactive ingredients

INACTIVE INGREDIENT SECTION

lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Non-Drowsy Allergy Relief
Non-Drowsy Allergy Relief

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53117-40753117-407-85

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 · Source PDF

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
A076471-001LORATADINELORATADINE10MGTABLET / ORAL2006-02-14

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 13:18:302026-09A076471-001LORATADINE10MGTABLET / ORAL2006-02-14c2088c7a36db…
2026-09-14 22:38:342026-08A076471-001LORATADINE10MGTABLET / ORAL2006-02-1484e616aacf4f…
2026-08-18 06:07:402026-07A076471-001LORATADINE10MGTABLET / ORAL2006-02-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076471-001LORATADINE10MGTABLET / ORAL2006-02-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076471-001LORATADINE10MGTABLET / ORAL2006-02-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A076471-001LORATADINE10MGTABLET / ORAL2006-02-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076471-001LORATADINE10MGTABLET / ORAL2006-02-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076471-001LORATADINE10MGTABLET / ORAL2006-02-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076471-001LORATADINE10MGTABLET / ORAL2006-02-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076471-001LORATADINE10MGTABLET / ORAL2006-02-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076471-001LORATADINE10MGTABLET / ORAL2006-02-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076471-001LORATADINE10MGTABLET / ORAL2006-02-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076471-001LORATADINE10MGTABLET / ORAL2006-02-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076471-001LORATADINE10MGTABLET / ORAL2006-02-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076471-001LORATADINE10MGTABLET / ORAL2006-02-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076471-001LORATADINE10MGTABLET / ORAL2006-02-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076471-001LORATADINE10MGTABLET / ORAL2006-02-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076471-001LORATADINE10MGTABLET / ORAL2006-02-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076471-001LORATADINE10MGTABLET / ORAL2006-02-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076471-001LORATADINE10MGTABLET / ORAL2006-02-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076471-001LORATADINE10MGTABLET / ORAL2006-02-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076471-001LORATADINE10MGTABLET / ORAL2006-02-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076471-001LORATADINE10MGTABLET / ORAL2006-02-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076471-001LORATADINE10MGTABLET / ORAL2006-02-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A076471-001LORATADINE10MGTABLET / ORAL2006-02-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076471-001LORATADINE10MGTABLET / ORAL2006-02-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076471-001LORATADINE10MGTABLET / ORAL2006-02-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076471-001LORATADINE10MGTABLET / ORAL2006-02-143f01610625f2…
2019-09-15 20:21 UTC2019-09A076471-001LORATADINE10MGTABLET / ORAL2006-02-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A076471-001LORATADINE10MGTABLET / ORAL2006-02-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076471-001LORATADINE10MGTABLET / ORAL2006-02-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076471-001LORATADINE10MGTABLET / ORAL2006-02-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076471-001LORATADINE10MGTABLET / ORAL2006-02-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076471-001LORATADINE10MGTABLET / ORAL2006-02-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076471-001LORATADINE10MGTABLET / ORAL2006-02-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076471-001LORATADINE10MGTABLET / ORAL2006-02-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076471-001LORATADINE10MGTABLET / ORAL2006-02-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A076471-001LORATADINE10MGTABLET / ORAL2006-02-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A076471-001LORATADINE10MGTABLET / ORAL2006-02-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076471-001LORATADINE10MGTABLET / ORAL2006-02-143a93d1ddd44b…

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
acb8f014-82e0-4758-8779-621a1c36002bf47f9973-90e3-463c-a4a4-e7b9254620892019-09-20WarningsExact identifier
spl set id: f47f9973-90e3-463c-a4a4-e7b925462089

Reported adverse events (FAERS/openFDA)#

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