Allergy Relief

Manufacturer
Allegiant Health
Effective date
2018-11-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:40:19

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. No 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. You may report side effects to 1-888-952-0050.

Pregnancy/Breastfeeding

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 accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years and over: 1 tablet daily. No 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 imprinted seal under safety cap is brokenor missing [for bottle]
  • do not use if blister unit is torn or open [for blister]

Inactive ingredients

INACTIVE INGREDIENT SECTION

 croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide 

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Allergy Relief
Allergy Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311372loratadine 10 MG 24HR Oral TabletPSN6
311372loratadine 10 MG Oral TabletSCD6
311372loratadine 10 MG 24 HR Oral TabletSY6

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-309-03Allergy Relief30 in 1 BLISTER PACKTABLET306
69168-309-08Allergy Relief5 in 1 BLISTER PACKTABLET56
69168-309-08Allergy Relief1 in 1 CARTONTABLET16
69168-309-09Allergy Relief10 in 1 BLISTER PACKTABLET106
69168-309-09Allergy Relief1 in 1 CARTONTABLET16
69168-309-10Allergy Relief1000 in 1 BOTTLETABLET10006
69168-309-30Allergy Relief1 in 1 CARTONTABLET16
69168-309-30Allergy Relief30 in 1 BOTTLETABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-309ALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]6Current NDC, Legacy NDC, 8 package rows20241206_0991388a-2eb8-4913-9efc-adf411eddf3a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QN1
LORATADINEACTIVE MOIETY7AJO3BO7QN1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH481
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5X1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69168-30969168-309-08, 69168-309-09, 69168-309-30, 69168-309-10, 69168-309-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates

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
Allergy ReliefLORATADINEAllegiant Health0991388a-2eb8-4913-9efc-adf411eddf3a2018-11-08WarningsExact identifier
ndc (package): 69168-309-30
ndc (package): 69168-309-10
ndc (package): 69168-309-09
ndc (package): 69168-309-08
ndc (package): 69168-309-03
ndc (product): 69168-309
ndc11 (package): 69168030910
ndc11 (package): 69168030909
ndc11 (package): 69168030930
ndc11 (package): 69168030908
ndc11 (package): 69168030903
spl id: 520a7a7c-a1a5-48a6-b472-9d47a4463452
spl set id: 0991388a-2eb8-4913-9efc-adf411eddf3a

Reported adverse events (FAERS/openFDA)#

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