ALLERGY RELIEF

Manufacturer
Rite Aid Corporation | Bionpharma Inc. | Patheon Softgels Inc.
Effective date
2021-05-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:39

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 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

Safety sealed: do not use if individual blister unit printed with Loratadine Capsule, 10 mg is open or torn. 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

  • Safety sealed: do not use if individual blister unit printed with Loratadine Capsule, 10 mg is open or torn.
  • 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®.

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

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE,

CAMP HILL, PA17011

www.riteaid.com

SATISFACTION

GUARANTEE

If you're not satisfied, we'll

happily refund your money.

Lot#

Expiration Date

Rev# 04/21

L0000439

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11822-2022-3

Original Prescription Strength

Compare to the active ingredient in Claritin® Liqui-Gels®*

ALLERGY RELIEF

LORATADINE CAPSULES, 10 mg

ANTIHISTAMINE

NON-DROWSY*

INDOOR/OUTDOOR ALLERGIES

24 HOUR RELIEF OF

Sneezing • Runny nose • Itchy, watery eyes

Itchy throat or nose

Actual Size

10 SOFTGELS**

(1X10) (**LIQUID-FILLED CAPSULES)

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

5's Carton5's Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
828269loratadine 10 MG 24HR Oral CapsulePSN1
828269loratadine 10 MG Oral CapsuleSCD1
828269loratadine 10 MG 24HR Oral CapsuleSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-2022-32025-01-30C16284748780-12cef2736-96eb-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-2022-3ALLERGY RELIEF10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED101
11822-2022-3ALLERGY RELIEF1 in 1 CARTONCAPSULE, LIQUID FILLED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-2022ALLERGY RELIEF (LORATADINE) CAPSULE, LIQUID FILLED [RITE AID CORPORATION]1Legacy NDC, 2 package rows20210601_c3413e54-489c-036f-e053-2995a90a8087.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-202211822-2022-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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 1.

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-09-29 23:25 UTC2022-09A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21cb3db0bc1861…

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
c3413e54-489d-036f-e053-2995a90a8087c3413e54-489c-036f-e053-2995a90a80872021-05-26WarningsExact identifier
spl id: c3413e54-489d-036f-e053-2995a90a8087
spl set id: c3413e54-489c-036f-e053-2995a90a8087