FDA.reportPublic FDA data

Loratadine Tablets, 10 mg

Manufacturer
Granules Pharmaceuticals Inc.
Effective date
2025-05-05
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:00:34

Label at a glance#

ProductLoratadine
Active ingredientLORATADINE
Label structure16 sections

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

store between 20º to 25ºC (68º to 77ºF)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Loratadine 10 mg

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

USE(S)

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

 runny nose


 sneezing

 itchy, water eyes

 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

OTC - ASK DOCTOR SECTION

you have 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 DOCTOR IF

OTC - STOP USE SECTION

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

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 overdose, get medical help or contact a Poison Control Center right away.

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

Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

STORAGE

STORAGE AND HANDLING SECTION

store between 20º to 25ºC (68º to 77ºF)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized

QUESTIONS OR COMMENTS

SPL UNCLASSIFIED SECTION

Contact 1-877-770-3183: Mon-Fri 8:00 AM EST to 5:00 PM PST.

PRINCIPAL DISPLAY PANEL-Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70010-162-03
**Compare to the active ingredient
in Claritin®

NON-DROWSY*

Loratadine
Tablets, USP
10 mg
Antihistamine

Indoor & Outdoor Allergies

Relief of:
• Sneezing • Runny Nose
• Itchy, Watery Eyes • Itchy Throat or Nose

30 Tablets *When taken as directed.
See Drug Facts Panel.

loratadine-30s-label1loratadine-30s-label1

loratadine-30s-label2loratadine-30s-label2

PRINCIPAL DISPLAY PANEL-Container Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70010-162-03 **Compare to the active ingredient in Claritin®

NON-DROWSY*

Loratadine Tablets, USP
10 mg
Antihistamine

Indoor & Outdoor Allergies

Relief of:
• Sneezing

• Runny Nose
• Itchy, Watery Eyes 30 Tablets

• Itchy Throat or Nose *When taken as directed. See Drug Facts Panel.

loratadine-30s-cartonloratadine-30s-carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311372loratadine 10 MG 24HR Oral TabletPSN5
311372loratadine 10 MG Oral TabletSCD5
311372loratadine 10 MG 24 HR Oral TabletSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70010-162-01Loratadine100 in 1 BOTTLETABLET1005
70010-162-03Loratadine30 in 1 BOTTLETABLET305
70010-162-34Loratadine300 in 1 BOTTLETABLET3005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-162LORATADINE TABLET [GRANULES PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 3 package rows20250508_d15add22-bc2d-9730-e053-2a95a90acd3f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-162-01EA - Each70010-162590b49a0-7416-4a5b-9ef6-cdc10a4b3a3f12021-12-08
70010-162-34EA - Each70010-1629d40ed54-0327-411e-9606-1ffef0f56c9012022-09-12

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
70010-16270010-162-01, 70010-162-34, 70010-162-03

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
STARCH, CORNO8232NY3SJIACT
MAGNESIUM STEARATE70097M6I30IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
LORATADINE7AJO3BO7QNACTIB

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 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
A210722-001LORATADINELORATADINE10MGTABLET / ORAL2019-12-23

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 22:38:342026-08A210722-001LORATADINE10MGTABLET / ORAL2019-12-2384e616aacf4f…
2026-08-18 06:07:402026-07A210722-001LORATADINE10MGTABLET / ORAL2019-12-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210722-001LORATADINE10MGTABLET / ORAL2019-12-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210722-001LORATADINE10MGTABLET / ORAL2019-12-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A210722-001LORATADINE10MGTABLET / ORAL2019-12-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210722-001LORATADINE10MGTABLET / ORAL2019-12-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210722-001LORATADINE10MGTABLET / ORAL2019-12-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210722-001LORATADINE10MGTABLET / ORAL2019-12-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210722-001LORATADINE10MGTABLET / ORAL2019-12-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210722-001LORATADINE10MGTABLET / ORAL2019-12-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210722-001LORATADINE10MGTABLET / ORAL2019-12-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210722-001LORATADINE10MGTABLET / ORAL2019-12-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210722-001LORATADINE10MGTABLET / ORAL2019-12-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210722-001LORATADINE10MGTABLET / ORAL2019-12-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210722-001LORATADINE10MGTABLET / ORAL2019-12-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210722-001LORATADINE10MGTABLET / ORAL2019-12-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210722-001LORATADINE10MGTABLET / ORAL2019-12-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210722-001LORATADINE10MGTABLET / ORAL2019-12-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210722-001LORATADINE10MGTABLET / ORAL2019-12-234b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210722-001LORATADINE10MGTABLET / ORAL2019-12-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210722-001LORATADINE10MGTABLET / ORAL2019-12-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210722-001LORATADINE10MGTABLET / ORAL2019-12-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A210722-001LORATADINE10MGTABLET / ORAL2019-12-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210722-001LORATADINE10MGTABLET / ORAL2019-12-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210722-001LORATADINE10MGTABLET / ORAL2019-12-23c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210722-001LORATADINE10MGTABLET / ORAL2019-12-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210722-001LORATADINE10MGTABLET / ORAL2019-12-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210722-001LORATADINE10MGTABLET / ORAL2019-12-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210722-001LORATADINE10MGTABLET / ORAL2019-12-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210722-001LORATADINE10MGTABLET / ORAL2019-12-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210722-001LORATADINE10MGTABLET / ORAL2019-12-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210722-001LORATADINE10MGTABLET / ORAL2019-12-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A210722-001LORATADINE10MGTABLET / ORAL2019-12-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A210722-001LORATADINE10MGTABLET / ORAL2019-12-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210722-001LORATADINE10MGTABLET / ORAL2019-12-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210722-001LORATADINE10MGTABLET / ORAL2019-12-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210722-001LORATADINE10MGTABLET / ORAL2019-12-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210722-001LORATADINE10MGTABLET / ORAL2019-12-23cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210722-001LORATADINE10MGTABLET / ORAL2019-12-23a50c72e98297…

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
LoratadineLORATADINEGranules Pharmaceuticals Inc.d15add22-bc2d-9730-e053-2a95a90acd3f2025-05-05WarningsExact identifier
ndc (package): 70010-162-34
ndc (package): 70010-162-01
ndc (package): 70010-162-03
ndc (product): 70010-162
ndc11 (package): 70010016201
ndc11 (package): 70010016203
ndc11 (package): 70010016234
spl id: 346155e4-f155-2f14-e063-6294a90ac61f
spl set id: d15add22-bc2d-9730-e053-2a95a90acd3f

Reported adverse events (FAERS/openFDA)#

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