FDA.reportPublic FDA data

Claritin-D

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-05
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:20:28

Label at a glance#

ProductClaritin-D 24 Hour
Active ingredientLORATADINE, PSEUDOEPHEDRINE SULFATE
Label structure9 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 temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

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

Storage and handling

each tablet contains: calcium 25 mg safety sealed: do not use if the individual blister unit imprinted with Claritin-D ® 24 hour is open or torn store between 20° to 25°C (68° to 77°F) protect from light and store in a dry place

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (in each tablet)Purpose
Loratadine 10 mgAntihistamine
Pseudoephedrine sulfate 240 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • 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
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • reduces swelling of nasal passages
  • temporarily relieves sinus congestion and pressure
  • temporarily restores freer breathing through the nose

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

  • 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • 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.

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.
  • symptoms do not improve within 7 days or are accompanied by a fever
  • nervousness, dizziness or sleeplessness occurs

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not divide, crush, chew or dissolve the tablet
adults and children 12 years and over1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours
children under 12 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 25 mg
  • safety sealed: do not use if the individual blister unit imprinted with Claritin-D ® 24 hour is open or torn
  • store between 20° to 25°C (68° to 77°F)
  • protect from light and store in a dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, dibasic calcium phosphate dihydrate, ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, pharmaceutical ink, polyethylene glycol, povidone, silicon dioxide, sucrose, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-CLARITIN (1-800-252-7484) or www.claritin.com

PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11523-4332-1

Non-Drowsy*

Claritin-D ®

pseudoephedrine sulfate 240 mg/nasal decongestant

loratadine 10 mg/antihistamine

Indoor & Outdoor Allergies

Allergy & Congestion

24

Hour

Relief of:

Nasal & Sinus Congestion

Due to Colds or Allergies

Sneezing; Runny Nose;

Itchy, Watery Eyes;

Itchy Throat or Nose

Due to Allergies

* When taken as directed. See Drug Facts Panel.

5

EXTENDED

RELEASE TABLETS

PDPPDPPDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1242391Claritin-D 10 MG / 240 MG 24HR Extended Release Oral TabletPSN11
1117562pseudoephedrine sulfate 240 MG / loratadine 10 MG 24HR Extended Release Oral TabletPSN11
124239124 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral Tablet [Claritin-D]SBD11
111756224 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral TabletSCD11
1242391Claritin-D (loratadine 10 MG / pseudoephedrine sulfate 240 MG) 24 HR Extended Release Oral TabletSY11
1117562loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Oral TabletSY11

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130041100810861GTIN-13: 0041100810861
EAN-13: 0041100810861
GTIN-12: 041100810861
UPC-A: 041100810861
GTIN storage (14 digits): 00041100810861		Claritin_D_24hr_10ct_Carton2.jpg

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
11523-4332-1Claritin-D24 Hour5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE511
11523-4332-1Claritin-D24 Hour1 in 1 CARTONTABLET, EXTENDED RELEASE111
11523-4332-2Claritin-D24 Hour1 in 1 CARTONTABLET, EXTENDED RELEASE111
11523-4332-2Claritin-D24 Hour10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1011
11523-4332-3Claritin-D24 Hour5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE511
11523-4332-3Claritin-D24 Hour3 in 1 CARTONTABLET, EXTENDED RELEASE311

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-4332-1EA - Each11523-433240164527-e89f-4a62-a521-2780a126ab2f12014-02-04
11523-4332-2EA - Each11523-4332b6e19e95-1862-4d66-9678-e88699aa923f12014-02-04
11523-4332-3EA - Each11523-433251f9fc16-f263-466f-a344-dfc904651d1112014-02-04

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-433211523-4332-1, 11523-4332-2, 11523-4332-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARNAUBA WAXR12CBM0EIZIACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSES3NXW29V3WOIACT
ETHYLCELLULOSES7Z8S9VYZ4BIACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCROSEC151H8M554IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
LORATADINE7AJO3BO7QNACTIB
PSEUDOEPHEDRINE SULFATEY9DL7QPE6BACTIB

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
N020470-002CLARITIN-D 24 HOURLORATADINE; PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-27

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 13:18:302026-09N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-27c2088c7a36db…
2026-09-14 22:38:342026-08N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-2784e616aacf4f…
2026-08-18 06:07:402026-07N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-2787673890dc5c…
2021-03-12 10:30 UTC2021-03N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-273f01610625f2…
2019-09-15 20:21 UTC2019-09N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-27b00525d2431f…
2019-07-19 19:46 UTC2019-07N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-273f0d92c62455…
2023-05-13 08:27 UTC2023-05N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-27053a50430f4f…
2023-01-26 05:58 UTC2023-01N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020470-002CLARITIN-D 24 HOUR10MG;240MGTABLET, EXTENDED RELEASE / ORALRLD, RS2002-11-273a93d1ddd44b…

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
Claritin-D 24 HourLORATADINE AND PSEUDOEPHEDRINE SULFATEBayer HealthCare LLC.f046a807-ab8c-0620-e053-2a95a90a9d3c2025-12-05WarningsExact identifier
ndc (package): 11523-4332-3
ndc (package): 11523-4332-1
ndc (package): 11523-4332-2
ndc (product): 11523-4332
ndc11 (package): 11523433203
ndc11 (package): 11523433202
ndc11 (package): 11523433201
spl id: 45370575-1a5d-c6f1-e063-6394a90a24c4
spl set id: f046a807-ab8c-0620-e053-2a95a90a9d3c

Reported adverse events (FAERS/openFDA)#

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