FDA.reportPublic FDA data

LORATADINE

Manufacturer
Bionpharma Inc. | Patheon Softgels Inc.
Effective date
2024-12-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:48:25

Label at a glance#

ProductLORATADINE
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

adults and children 6 years and over 1 capsule daily; not more than 1 capsule in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Storage and handling

Tamper-evident: do not use if foil seal under cap, printed with “Sealed for your protection” is missing, open or broken. (For Bottle Labels and Cartons) Safety sealed: do not use if individual blister unit printed with Loratadine Capsule, 10 mg is open or torn. (For Blister Carton) store between 20° to 25°C (68° to 77°F) protect from freezing

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Loratadine 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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years and over

1 capsule daily; not more than 1 capsule in 24 hours

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • Tamper-evident: do not use if foil seal under cap, printed with “Sealed for your protection” is missing, open or broken. (For Bottle Labels and Cartons)
  • Safety sealed: do not use if individual blister unit printed with Loratadine Capsule, 10 mg is open or torn. (For Blister Carton)
  • store between 20° to 25°C (68° to 77°F)
  • protect from freezing

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue no.1, gelatin, glycerin, hypromellose, hydrolyzed collagen, isopropyl alcohol, mannitol, medium chain mono- & di-glycerides, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

SPL UNCLASSIFIED SECTION

†This product is not manufactured or distributed by the owners of Claritin® LIQUI-GELS®.

Blister carton contain the following:

THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Do not use if carton is open, or if individual blister unit is open or torn

Manufactured for:

Bionpharma Inc.

600 Alexander Road,

Princeton, NJ 08540

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5's Carton5's Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
828269loratadine 10 MG 24HR Oral CapsulePSN5
828269loratadine 10 MG Oral CapsuleSCD5
828269loratadine 10 MG 24HR Oral CapsuleSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-283-17LORATADINE60 in 1 BOTTLECAPSULE, LIQUID FILLED605
69452-283-17LORATADINE1 in 1 CARTONCAPSULE, LIQUID FILLED15
69452-283-19LORATADINE90 in 1 BLISTER PACKCAPSULE, LIQUID FILLED905
69452-283-19LORATADINE1 in 1 CARTONCAPSULE, LIQUID FILLED15
69452-283-25LORATADINE180 in 1 BOTTLECAPSULE, LIQUID FILLED1805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-283LORATADINE CAPSULE, LIQUID FILLED [BIONPHARMA INC.]5Current NDC, Legacy NDC, 5 package rows20241225_4fa705fb-859e-4046-b153-a8338c50a97d.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69452-28369452-283-19, 69452-283-25, 69452-283-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPRYLIC/CAPRIC ACIDDI775RT244IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
HYPROMELLOSES3NXW29V3WOIACT
HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW)5WE8P977RQIACT
ISOPROPYL ALCOHOLND2M416302IACT
MANNITOL3OWL53L36AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
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
A202538-001LORATADINELORATADINE10MGCAPSULE / ORAL2018-12-21

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-2184e616aacf4f…
2026-08-18 06:07:402026-07A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-213f01610625f2…
2019-09-15 20:21 UTC2019-09A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21f41ea6bd6efb…

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
LORATADINELORATADINEBionpharma Inc.4fa705fb-859e-4046-b153-a8338c50a97d2024-12-23WarningsExact identifier
ndc (package): 69452-283-25
ndc (package): 69452-283-17
ndc (package): 69452-283-19
ndc (product): 69452-283
ndc11 (package): 69452028325
ndc11 (package): 69452028319
ndc11 (package): 69452028317
spl id: 29f9d1b7-7751-f253-e063-6394a90ac12f
spl set id: 4fa705fb-859e-4046-b153-a8338c50a97d

Reported adverse events (FAERS/openFDA)#

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