Allergy Relief

Manufacturer
Ohm Laboratories Inc.
Effective date
2021-04-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:39:29

Label at a glance#

ProductAllergy Relief
Active ingredientLORATADINE
Label structure9 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

• place 1 tablet on tongue; tablet disintegrates, with or without water 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 (IN EACH TABLET)

OTC - ACTIVE INGREDIENT SECTION

Loratadine USP, 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

  • place 1 tablet on tongue; tablet disintegrates, with or without water

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

  • Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet.
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25° C (68° to 77° F). Protect from excessive moisture.
  • use tablet immediately after opening individual blister.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aspartame, croscarmellose sodium, magnesium stearate, mannitol, mint flavor, sodium stearyl fumarate, strawberry cream flavor, tutti-frutti flavor

QUESTIONS?

OTC - QUESTIONS SECTION

Call 1-800-406-7984

directions
directions

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare To the active ingredient of Claritin® RediTabs®

NDC 51660-527-31

ohm®

Original Prescription Strength

NON-DROWSY*

Ages 6 years and older

Loratadine Orally Disintegrating Tablets USP, 10 mg

ANTIHISTAMINE

Allergy Relief

Indoor & Outdoor Allergies

No Water Needed

  1. • Melts in Your Mouth

24 HOUR

Relief of:

  • Sneezing
  • Itchy, Watery Eyes
  • Runny Nose
  • Itchy Throat or Nose

30 Orally Disintegrating Tablets

*When taken as directed. See Drug Facts Panel.

Distributed by: Ohm Laboratories Inc.

5217818/R0321

ohmloraodtnew
ohmloraodtnew

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSN6
311373loratadine 10 MG Disintegrating Oral TabletSCD6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51660-527-312021-04-06C16284748780-19d75b9d0-a8c7-f424-e053-dadaa90a57ceDrug Facts
51660-527-312020-01-31C16284748780-19d75b9d0-a8c7-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51660-527-31Allergy Relief30 in 1 CARTONTABLET, ORALLY DISINTEGRATING306
51660-527-31Allergy Relief1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-527ALLERGY RELIEF (LORATADINE) TABLET, ORALLY DISINTEGRATING [OHM LABORATORIES INC.]6Current NDC, Legacy NDC, 2 package rows20210407_de3a7725-5d1b-4195-a9f8-43f92888997c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51660-527-31EA - Each51660-5272f06cc31-d825-4951-ad09-c82e0a47a14c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QN5
LORATADINEACTIVE MOIETY7AJO3BO7QN5
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR15
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH485
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I305
MANNITOLINACTIVE INGREDIENT3OWL53L36A5
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UI5

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
51660-52751660-527-31

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 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, ORALLY DISINTEGRATING / ORAL184 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, ORALLY DISINTEGRATING / ORAL180 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, ORALLY DISINTEGRATING / ORAL180 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING / ORAL187 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, ORALLY DISINTEGRATING / ORAL4364 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, ORALLY DISINTEGRATING / ORAL184 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, ORALLY DISINTEGRATING / ORAL4364 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING / ORAL187 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM STEARYL FUMARATESODIUM STEARYL FUMARATE7CV7WJK4UITABLET, ORALLY DISINTEGRATING / ORAL153 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM STEARYL FUMARATESODIUM STEARYL FUMARATE7CV7WJK4UITABLET, ORALLY DISINTEGRATING / ORAL153 mgExact identifier — unii+route+dosage form
2 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
A077153-001LORATADINE REDIDOSELORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11

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 13:18:302026-09A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11c2088c7a36db…
2026-09-14 22:38:342026-08A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-1184e616aacf4f…
2026-08-18 06:07:402026-07A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-113f01610625f2…
2019-09-15 20:21 UTC2019-09A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-113a93d1ddd44b…

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 ReliefLORATADINEOhm Laboratories Inc.de3a7725-5d1b-4195-a9f8-43f92888997c2021-04-06WarningsExact identifier
ndc (package): 51660-527-31
ndc (product): 51660-527
ndc11 (package): 51660052731
spl id: 7b87d8ea-1102-4642-8a39-b2504dbda716
spl set id: de3a7725-5d1b-4195-a9f8-43f92888997c

Reported adverse events (FAERS/openFDA)#

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