FDA.reportPublic FDA data

Allergy Relief

Manufacturer
GOODSENSE
Effective date
2025-12-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:21:22

Label at a glance#

ProductAllergy Relief
Active ingredientLORATADINE
Label structure10 sections

Indications and uses

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

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

• Store between 20-25˚C (68-77˚F) • protect from freezing • retain carton for complete information and warnings

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

• sneezing

• itchy, water eyes

• itching of the nose or throat



Warnings

WARNINGS SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

OTC - WHEN USING SECTION

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

OTC - STOP USE SECTION

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  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 over1 capsule daily; not more than 1 capsule in 24 hours
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

STORAGE AND HANDLING SECTION

• Store between 20-25˚C (68-77˚F)

• protect from freezing

• retain carton for complete information and warnings

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue no. 1, gelatine, mono anddiglyceride of caprilic/capric acid, pharmaceutical ink, polysorbate 80,povidone, purified water, sorbitol, sorbitan solution.

Questions or Comments?

OTC - QUESTIONS SECTION

1-844-705-4384

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOODSENSE®

NDC 50804-840-10          

Non-Drowsy*

*When taken as directed. See Drug Facts Panel.

24 Hour

Allergy Relief

Loratadine Capsules, 10mg / Antihistamine

Indoor & Outdoor Allergies

• Sneezing •Runny Nose

• Itchy, Watery Eyes • Itchy Throat or Nose

10 SOFTGELS**

(**Liquid-Filled Capsules)

Compare to the active ingredient of Claritin® Liqui-Gels®

image descriptionimage description

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130846036008401GTIN-13: 0846036008401
EAN-13: 0846036008401
GTIN-12: 846036008401
UPC-A: 846036008401
GTIN storage (14 digits): 00846036008401		F1195A02GDS_R1.jpg
Data codeData MatrixF1195A02GDS_R1F1195A02GDS_R1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-840-10Allergy Relief1 in 1 CARTONCAPSULE, LIQUID FILLED15
50804-840-10Allergy Relief10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-840-10EA - Each50804-8400a56ab1b-4cbb-4cbe-aec3-71089f880d4e12022-03-09

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50804-84050804-840-10

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
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
CAPRIC ACID4G9EDB6V73IACT
POVIDONE K30U725QWY32XIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
POLYSORBATE 806OZP39ZG8HIACT
SORBITAN6O92ICV9RUIACT
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 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
458c2295-eb05-1ae6-e063-6394a90a6c79969b7d4b-fb07-4f44-af71-3e5eed9227932025-12-09WarningsExact identifier
spl id: 458c2295-eb05-1ae6-e063-6394a90a6c79
spl set id: 969b7d4b-fb07-4f44-af71-3e5eed922793

Reported adverse events (FAERS/openFDA)#

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