Loratadine tablets USP, 10mg/antihistamine

Manufacturer
Bryant Ranch Prepack
Effective date
2025-06-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:03:26

Label at a glance#

ProductLoratadine
Active ingredientLORATADINE
Label structure15 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#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)
Loratadine USP, 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
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

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.

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

Bottles:

  • 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)

Blisters packs:

  • safety sealed: do not use if the individual blister unit imprinted with loratadine is open or torn
  • store between 20° to 25°C (68° to 77°F)
  • protect from excessive moisture

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION


corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

QUESTIONS OR COMMENTS?

SPL UNCLASSIFIED SECTION

Call 1-888-588-1418

HOW SUPPLIED

How Supplied Section

Loratadine 10mg Tablet

  • NDC 71335-2391-1: 20 Tablets in a BOTTLE
  • NDC 71335-2391-2: 30 Tablets in a BOTTLE
  • NDC 71335-2391-3: 60 Tablets in a BOTTLE
  • NDC 71335-2391-4: 14 Tablets in a BOTTLE
  • NDC 71335-2391-5: 10 Tablets in a BOTTLE
  • NDC 71335-2391-6: 90 Tablets in a BOTTLE
  • NDC 71335-2391-7: 28 Tablets in a BOTTLE
  • NDC 71335-2391-8: 15 Tablets in a BOTTLE
  • NDC 71335-2391-9: 100 Tablets in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Loratadine 10mg Tablet

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311372loratadine 10 MG 24HR Oral TabletPSN1
311372loratadine 10 MG Oral TabletSCD1
311372loratadine 10 MG 24 HR Oral TabletSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2391-1Loratadine20 in 1 BOTTLETABLET201
71335-2391-2Loratadine30 in 1 BOTTLETABLET301
71335-2391-3Loratadine60 in 1 BOTTLETABLET601
71335-2391-4Loratadine14 in 1 BOTTLETABLET141
71335-2391-5Loratadine10 in 1 BOTTLETABLET101
71335-2391-6Loratadine90 in 1 BOTTLETABLET901
71335-2391-7Loratadine28 in 1 BOTTLETABLET281
71335-2391-8Loratadine15 in 1 BOTTLETABLET151
71335-2391-9Loratadine100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2391-1EA - Each71335-23914fc06ac6-23bc-471d-bbdf-1cbf50ce3e2c12026-01-08
71335-2391-2EA - Each71335-23916c035bd3-b72c-40ef-9462-42dc3e65c1a812025-11-13
69230-323-30EA - Each69230-323201bb70e-fb9b-4500-b71b-0f6a81ae449612024-04-05
69230-323-33EA - Each69230-32309fff6b2-e4ce-4023-a5aa-e9130a7fc06712024-04-05
69230-323-34EA - Each69230-3236fb9ba44-5272-4816-918a-5e1b0ef886c112024-04-05

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
A211718-001LORATADINELORATADINE10MGTABLET / ORAL2023-07-28

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 22:38:342026-08A211718-001LORATADINE10MGTABLET / ORAL2023-07-2884e616aacf4f…
2026-08-18 06:07:402026-07A211718-001LORATADINE10MGTABLET / ORAL2023-07-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211718-001LORATADINE10MGTABLET / ORAL2023-07-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211718-001LORATADINE10MGTABLET / ORAL2023-07-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211718-001LORATADINE10MGTABLET / ORAL2023-07-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211718-001LORATADINE10MGTABLET / ORAL2023-07-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211718-001LORATADINE10MGTABLET / ORAL2023-07-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211718-001LORATADINE10MGTABLET / ORAL2023-07-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211718-001LORATADINE10MGTABLET / ORAL2023-07-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211718-001LORATADINE10MGTABLET / ORAL2023-07-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211718-001LORATADINE10MGTABLET / ORAL2023-07-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211718-001LORATADINE10MGTABLET / ORAL2023-07-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211718-001LORATADINE10MGTABLET / ORAL2023-07-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211718-001LORATADINE10MGTABLET / ORAL2023-07-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211718-001LORATADINE10MGTABLET / ORAL2023-07-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211718-001LORATADINE10MGTABLET / ORAL2023-07-288072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211718-001LORATADINE10MGTABLET / ORAL2023-07-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211718-001LORATADINE10MGTABLET / ORAL2023-07-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211718-001LORATADINE10MGTABLET / ORAL2023-07-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211718-001LORATADINE10MGTABLET / ORAL2023-07-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211718-001LORATADINE10MGTABLET / ORAL2023-07-289b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211718-001LORATADINE10MGTABLET / ORAL2023-07-28a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LoratadineLORATADINEBryant Ranch Prepackbaad51cd-daa0-4920-a6d5-2faaaaea79562025-06-18WarningsExact identifier
ndc (package): 71335-2391-6
ndc (package): 71335-2391-1
ndc (package): 71335-2391-5
ndc (package): 71335-2391-4
ndc (package): 71335-2391-9
ndc (package): 71335-2391-8
ndc (package): 71335-2391-3
ndc (package): 71335-2391-7
ndc (package): 71335-2391-2
ndc (product): 71335-2391
ndc11 (package): 71335239106
ndc11 (package): 71335239109
ndc11 (package): 71335239107
ndc11 (package): 71335239108
ndc11 (package): 71335239102
ndc11 (package): 71335239103
ndc11 (package): 71335239105
ndc11 (package): 71335239104
ndc11 (package): 71335239101
spl id: 18eab889-2148-4233-aca0-38b185d5934d
spl set id: baad51cd-daa0-4920-a6d5-2faaaaea7956
LoratadineLORATADINECamber Consumer Care Incd57da4bd-af37-414a-a50c-e80d2bb283142023-09-08WarningsExact identifier
ndc (product): 69230-323

Reported adverse events (FAERS/openFDA)#

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