Allergy Relief

Manufacturer
CHAIN DRUG MARKETING ASSOCIATION INC.
Effective date
2024-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:40:29

Label at a glance#

ProductAllergy Relief
Active ingredientLORATADINE
Label structure14 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.

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

• 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.

Ask a doctor before use if

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children6 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

SPL UNCLASSIFIED SECTION

• store between 20-25˚C (68-77˚F)

• protect from freezing

• retain carton for complete product information

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue #1, gelatin, mono and diglyceride 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

Quality Choice®

NDC 63868-669-10

*Compare to the Active Ingredient in CLARITIN® Liqui-Gels®

Non-Drowsy†

Allergy Relief

Loratadine 10 mg | Antihistamine

Indoor & Outdoor Allergies

Relief of:

Sneezing | Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

24 Hour

†When taken as directed. See Drug Facts Panel.

10 Softgels**

**Liquid-Filled Capsules

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
828269loratadine 10 MG 24HR Oral CapsulePSN2
828269loratadine 10 MG Oral CapsuleSCD2
828269loratadine 10 MG 24HR Oral CapsuleSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-669-10Allergy Relief10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102
63868-669-10Allergy Relief1 in 1 CARTONCAPSULE, LIQUID FILLED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-669ALLERGY RELIEF (LORATADINE) CAPSULE, LIQUID FILLED [CHAIN DRUG MARKETING ASSOCIATION INC.]2Legacy NDC, 2 package rows20241207_18eaaeb7-1408-4621-bf88-1dc5cb06a9b3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-669-10EA - Each63868-6694e496eaf-881a-46ff-930d-1a1af553584912022-10-06

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
63868-66963868-669-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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 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
2873c175-17f4-0c99-e063-6394a90a277b18eaaeb7-1408-4621-bf88-1dc5cb06a9b32024-12-04WarningsExact identifier
spl id: 2873c175-17f4-0c99-e063-6394a90a277b
spl set id: 18eaaeb7-1408-4621-bf88-1dc5cb06a9b3

Reported adverse events (FAERS/openFDA)#

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