Loratadine Tablets, 10 mg

Manufacturer
Dr. Reddy's Laboratories Inc. | Granules India Limited
Effective date
2026-07-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
weekly-update
Hydrated at
2026-07-17 21:41:43

Label at a glance#

ProductAllergy Relief
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

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENT (IN EACH TABLET)

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, watery 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 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 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

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

■ store between 20° to 25° C (68° to 77°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

QUESTIONS OR COMMENTS

SPL UNCLASSIFIED SECTION

Contact 1-888-375-3784 weekdays (8 AM to 8 PM EST)

SPL UNCLASSIFIED SECTION

Distributed by:

Dr. Reddy’s Laboratories Inc.,

Princeton, NJ 08540

Made in India

**This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Claritin®.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 75907-434-30

*Non-Drowsy

Allergy Relief

Loratadine Tablets USP, 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 HR

Relief of:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

300 Tablets

*When taken as directed. See Drug Facts Panel

**Compare to the active ingredient in Claritin®

Container label
Container label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130375907434013GTIN-13: 0375907434013
EAN-13: 0375907434013
GTIN-12: 375907434013
UPC-A: 375907434013
GTIN storage (14 digits): 00375907434013
HCA Loratadine Tablets 10 mg 300 count bottle label.jpg
Data codeData Matrix200000006901HCA Loratadine Tablets 10 mg 300 count bottle label.jpg

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
75907-43475907-434-30, 75907-434-01

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

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
Allergy ReliefLORATADINEDr. Reddy's Laboratories Inc.44da36d2-1881-e779-d3a2-13ea828f92402026-07-15WarningsExact identifier
ndc (package): 75907-434-30
ndc (package): 75907-434-01
ndc (product): 75907-434
ndc11 (package): 75907043430
ndc11 (package): 75907043401
spl id: 87109b37-67cb-44f7-f158-1235c35aada3
spl set id: 44da36d2-1881-e779-d3a2-13ea828f9240

Reported adverse events (FAERS/openFDA)#

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