Claritin-D

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:19:44

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

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

  • store between 20° to 25°C (68° to 77°F)
  • protect from light and store in a dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

black iron oxide, candelilla wax powder, Inactive ingredients colloidal silicon dioxide, glyceryl monostearate, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, propylene glycol, sodium lauryl sulfate, talc, 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

FC008192_CLARITIN-D_CLARITIN-D24_TabletsFC008192_CLARITIN-D_CLARITIN-D24_Tablets

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1242391Claritin-D 10 MG / 240 MG 24HR Extended Release Oral TabletPSN9
1117562pseudoephedrine sulfate 240 MG / loratadine 10 MG 24HR Extended Release Oral TabletPSN9
124239124 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral Tablet [Claritin-D]SBD9
111756224 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral TabletSCD9
1242391Claritin-D (loratadine 10 MG / pseudoephedrine sulfate 240 MG) 24 HR Extended Release Oral TabletSY9
1117562loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Oral TabletSY9

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
11523-0102-1Claritin-D24 Hour1 in 1 CARTONTABLET, EXTENDED RELEASE19
11523-0102-1Claritin-D24 Hour10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE109
11523-0102-2Claritin-D24 Hour15 in 1 BLISTER PACKTABLET, EXTENDED RELEASE159
11523-0102-2Claritin-D24 Hour1 in 1 CARTONTABLET, EXTENDED RELEASE19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-0102-2EA - Each11523-0102b041a47b-0d88-472d-95c4-bc0de0fc496d12023-04-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QN1
pseudoephedrine sulfateACTIVE INGREDIENTY9DL7QPE6B1
LoratadineACTIVE MOIETY7AJO3BO7QN1
pseudoephedrineACTIVE MOIETY7CUC9DDI9F1
calcium phosphate, dibasic, dihydrateINACTIVE INGREDIENTO7TSZ97GEP1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZ1
ethylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4B1
hydroxypropyl cellulose (type h)INACTIVE INGREDIENTRFW2ET671P1
hypromellosesINACTIVE INGREDIENT3NXW29V3WO1
magnesium stearateINACTIVE INGREDIENT70097M6I301
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1A1
povidonesINACTIVE INGREDIENTFZ989GH94E1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU41
sucroseINACTIVE INGREDIENTC151H8M5541
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-010211523-0102-1, 11523-0102-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
calcium phosphate, dibasic, dihydrateDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, EXTENDED RELEASE / ORAL1036 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, EXTENDED RELEASE / ORAL101 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
hydroxypropyl cellulose (type h)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, EXTENDED RELEASE / ORAL864 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, EXTENDED RELEASE / ORAL1472 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sucroseSUCROSEC151H8M554TABLET, EXTENDED RELEASE / ORAL284.54 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, EXTENDED RELEASE / ORAL1472 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, EXTENDED RELEASE / ORAL90 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, EXTENDED RELEASE / ORAL101 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET, EXTENDED RELEASE / ORAL2150 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET, EXTENDED RELEASE / ORAL2150 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, EXTENDED RELEASE / ORAL450 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, EXTENDED RELEASE / ORAL101 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, EXTENDED RELEASE / ORAL90 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, EXTENDED RELEASE / ORAL450 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET, EXTENDED RELEASE / ORAL2150 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, EXTENDED RELEASE / ORAL450 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sucroseSUCROSEC151H8M554TABLET, EXTENDED RELEASE / ORAL284.54 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ethylcellulosesETHYLCELLULOSE7Z8S9VYZ4BTABLET, EXTENDED RELEASE / ORAL1120 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ethylcellulosesETHYLCELLULOSE7Z8S9VYZ4BTABLET, EXTENDED RELEASE / ORAL1120 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
calcium phosphate, dibasic, dihydrateDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, EXTENDED RELEASE / ORAL1036 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
hydroxypropyl cellulose (type h)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, EXTENDED RELEASE / ORAL864 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ethylcellulosesETHYLCELLULOSE7Z8S9VYZ4BTABLET, EXTENDED RELEASE / ORAL1120 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, EXTENDED RELEASE / ORAL90 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sucroseSUCROSEC151H8M554TABLET, EXTENDED RELEASE / ORAL284.54 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
hydroxypropyl cellulose (type h)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, EXTENDED RELEASE / ORAL864 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
calcium phosphate, dibasic, dihydrateDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, EXTENDED RELEASE / ORAL1036 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, EXTENDED RELEASE / ORAL1472 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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
A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATELORATADINE; PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-21

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-21c2088c7a36db…
2026-09-14 22:38:342026-08A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-2184e616aacf4f…
2026-08-18 06:07:402026-07A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-213f01610625f2…
2019-09-15 20:21 UTC2019-09A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-213a93d1ddd44b…

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 PSEUDOEPHEDRINE SULFATEBayer HealthCare LLC.3ea6a90b-8cb1-46b0-9ff7-be7090245e532025-12-04WarningsExact identifier
ndc (package): 11523-0102-1
ndc (package): 11523-0102-2
ndc (product): 11523-0102
ndc11 (package): 11523010201
ndc11 (package): 11523010202
spl id: 4526d9ef-02fb-338e-e063-6394a90af108
spl set id: 3ea6a90b-8cb1-46b0-9ff7-be7090245e53

Reported adverse events (FAERS/openFDA)#

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