FDA.reportPublic FDA data

Leader Allergy Relief D-24

Manufacturer
Cardinal Health | Ohm Laboratories Inc.
Effective date
2022-03-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:48:54

Label at a glance#

ProductLeader Allergy Relief D-24
Active ingredientLORATADINE, PSEUDOEPHEDRINE SULFATE
Label structure10 sections

Indications and uses

■ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:   ■ sneezing ■ itchy, watery eyes ■ runny nose ■ itching of the nose or throat ■ reduces swelling of nasal passages ■ temporarily relieves sinus congestion and pressure ■ temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies ■ temporarily restores freer breathing throu...

Dosage and administration

■ do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Loratadine, USP 10 mg

Pseudoephedrine Sulfate, USP 240 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  1. ■ sneezing ■ itchy, watery eyes ■ runny nose ■ itching of the nose or throat

■ reduces swelling of nasal passages

■ temporarily relieves sinus congestion and pressure

■ temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

■ temporarily restores freer breathing through the nose

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

■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  1. ■ heart disease ■ thyroid disease ■ high blood pressure ■ diabetes ■ trouble urinating due to an enlarged prostate gland

■ liver or kidney disease. Your doctor should determine if you need a different dose

  • .

When using this product do not take more than directed.

OTC - WHEN USING SECTION

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.

■ symptoms do not improve within 7 days or are accompanied by a fever

■ nervousness, dizziness or sleeplessness occurs

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

■ do not divide, crush, chew or dissolve the tablet

adults and children 12 years and over

1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours

children under 12 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other Information

OTHER SAFETY INFORMATION

  1. ■ sodium: contains 10 mg/tablet ■ calcium: contains 25 mg/tablet

■ TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only)

■ store between 20° C to 25° C (68° F to 77° F).

■ protect from light and store in a dry place

InactiveIngredients

INACTIVE INGREDIENT SECTION

calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide

Questions

OTC - QUESTIONS SECTION

call 1-800-406-7984

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70000-0162-1

Original Prescription Strength

*Compare to the active ingredients of Claritin-D® 24 Hour

NON-DROWSY*

Allergy Relief D-24

Loratadine, USP 10 mg/Antihistamine

Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

Indoor & Outdoor Allergies

Allergy & Congestion

Relief of:

Nasal & Sinus Congestion Due to Colds or Allergies

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose Due to Allergies

Allergy & Congestion

10 Extended-Release Tablets

*When taken as directed. See Drug Facts Panel.

Keep the carton. It contains important information.

see end panel for expiration date.

spl-10's-carton-label
spl-10's-carton-label

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70000-0162-2

Original Prescription Strength

*Compare to the active ingredients of Claritin-D® 24 Hour

NON-DROWSY**

Allergy Relief D-24

Loratadine, USP 10 mg/Antihistamine

Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

Indoor & Outdoor Allergies

Allergy & Congestion

Relief of:

Nasal & Sinus Congestion Due to Colds or Allergies

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose Due to Allergies

Allergy & Congestion

15 Extended-Release Tablets

*When taken as directed. See Drug Facts Panel.

Keep the carton. It contains important information.

see end panel for expiration date.

spl-15's-carton-label
spl-15's-carton-label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1117562pseudoephedrine sulfate 240 MG / loratadine 10 MG 24HR Extended Release Oral TabletPSN4
111756224 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral TabletSCD4
1117562loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Oral TabletSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0162-1Leader Allergy Relief D-2410 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE104
70000-0162-2Leader Allergy Relief D-2415 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0162LEADER ALLERGY RELIEF D-24 (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]4Current NDC, Legacy NDC, 2 package rows20220323_f1bcd2aa-e8cd-4364-87b4-c544537cdb50.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0162-1EA - Each70000-01626e30aa40-870a-4bad-84de-363b6910ee9712017-12-14
70000-0162-2EA - Each70000-01624f5c4e66-8076-41bb-9f08-5cafe168067b12017-09-11

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-016270000-0162-1, 70000-0162-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
LORATADINE7AJO3BO7QNACTIB
PSEUDOEPHEDRINE SULFATEY9DL7QPE6BACTIB
CALCIUM CARBONATEH0G9379FGKIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
STARCH, CORNO8232NY3SJIACT
SHELLAC46N107B71OIACT
SODIUM ALGINATEC269C4G2ZQIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT

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
A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATELORATADINE; PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-2284e616aacf4f…
2026-08-18 06:07:402026-07A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-223f01610625f2…
2019-09-15 20:21 UTC2019-09A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22f41ea6bd6efb…

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
Leader Allergy Relief D-24LORATADINE AND PSEUDOEPHEDRINE SULFATECardinal Healthf1bcd2aa-e8cd-4364-87b4-c544537cdb502022-03-22WarningsExact identifier
ndc (package): 70000-0162-1
ndc (package): 70000-0162-2
ndc (product): 70000-0162
ndc11 (package): 70000016201
ndc11 (package): 70000016202
spl id: 2aa29226-da73-4113-9dbd-ed13b345464d
spl set id: f1bcd2aa-e8cd-4364-87b4-c544537cdb50

Reported adverse events (FAERS/openFDA)#

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