FDA.reportPublic FDA data

Loratadine Liquid Filled Capsules, 10 mg (OTC) Drug Facts

Manufacturer
MARKSANS PHARMA LIMITED
Effective date
2021-11-15
Label type
Human OTC Drug Label
Version
3
Source
full-release
Hydrated at
2026-05-31 23:44:56

Label at a glance#

ProductLoratadine
Active ingredientLORATADINE
Label structure16 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.

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

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

Spl Unclassified 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

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 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue no. 1, gelatin, mono and diglyceride of caprylic/capric acid, pharmaceutical ink, polysorbate 80, povidone, purified water, sorbitol sorbitan solution.

Questions or comments?
Call at 1-877-376-4271


Other information

SPL UNCLASSIFIED SECTION

  • Store at 20°-25°C (68°-77°F)
  • protect from freezing.
  • Safety sealed: do not use if the individual blister unit imprinted with Loratadine Capsules is open or torn.

Manufactured for

SPL UNCLASSIFIED SECTION

Time-Cap Labs. Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA



Manufactured by

SPL UNCLASSIFIED SECTION

Marksans Pharma Ltd.
Plot No. L-82, L-83,
Verna Indl. Estate,
Verna, GOA 403722, India.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC# 25000-021-13
Loratadine Capsules, 10 mg
600 counts Bottle Label

600s-carton-label600s-carton-label

NDC# 25000-021-34
Loratadine Capsules, 10 mg
28 counts Blister Pack

28-carton-label28-carton-label

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC# 25000-021-36
Loratadine Capsules, 10 mg
3x10 carton Label



3x10
3x10


DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
828269loratadine 10 MG 24HR Oral CapsulePSN3
828269loratadine 10 MG Oral CapsuleSCD3
828269loratadine 10 MG 24HR Oral CapsuleSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25000-021-08Loratadine100 in 1 BOTTLECAPSULE, LIQUID FILLED1003
25000-021-13Loratadine600 in 1 BOTTLECAPSULE, LIQUID FILLED6003
25000-021-21Loratadine7500 in 1 BAGCAPSULE, LIQUID FILLED75003
25000-021-21Loratadine4 in 1 BOXCAPSULE, LIQUID FILLED43
25000-021-34Loratadine28 in 1 BLISTER PACKCAPSULE, LIQUID FILLED283
25000-021-36Loratadine3 in 1 CARTONCAPSULE, LIQUID FILLED33
25000-021-36Loratadine10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED103
25000-021-46Loratadine8 in 1 BOTTLECAPSULE, LIQUID FILLED83

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25000-021LORATADINE CAPSULE, LIQUID FILLED [MARKSANS PHARMA LIMITED]3Current NDC, Legacy NDC, 8 package rows20211117_c30907f9-1761-41e5-bd4e-2613e756e1c6.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
25000-02125000-021-08, 25000-021-13, 25000-021-46, 25000-021-34, 25000-021-21, 25000-021-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
LORATADINE7AJO3BO7QNACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
CAPRIC ACID4G9EDB6V73IACT
POVIDONE K30U725QWY32XIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
POLYSORBATE 806OZP39ZG8HIACT
SORBITAN6O92ICV9RUIACT

Source Document#

Source XML · Source PDF

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
A206214-001LORATADINELORATADINE10MGCAPSULE / ORAL2016-09-23

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.

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 13:18:302026-09A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23c2088c7a36db…
2026-09-14 22:38:342026-08A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-2384e616aacf4f…
2026-08-18 06:07:402026-07A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-233f01610625f2…
2019-09-15 20:21 UTC2019-09A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-233a93d1ddd44b…

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
LoratadineLORATADINEMARKSANS PHARMA LIMITEDc30907f9-1761-41e5-bd4e-2613e756e1c62021-11-15WarningsExact identifier
ndc (package): 25000-021-46
ndc (package): 25000-021-34
ndc (package): 25000-021-13
ndc (package): 25000-021-08
ndc (package): 25000-021-36
ndc (package): 25000-021-21
ndc (product): 25000-021
ndc11 (package): 25000002108
ndc11 (package): 25000002146
ndc11 (package): 25000002121
ndc11 (package): 25000002136
ndc11 (package): 25000002134
ndc11 (package): 25000002113
spl id: adf6c78c-edb1-4ffb-a934-d8cb772e621f
spl set id: c30907f9-1761-41e5-bd4e-2613e756e1c6

Reported adverse events (FAERS/openFDA)#

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