FDA.reportPublic FDA data

Loratadine and Pseudoephedrine Sulfate Extended-Release Tablets

Manufacturer
Actavis Pharma, Inc.
Effective date
2021-10-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:32:08

Label at a glance#

ProductAllergy Relief-D 24 Hour 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

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine, USP 10 mg
Pseudoephedrine sulfate, USP 240 mg

Purposes

OTC - PURPOSE SECTION

Antihistamine
Nasal 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

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

  • 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.

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

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

SPL UNCLASSIFIED SECTION

  • safety sealed: do not use if blister unit 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

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

Questions?

OTC - QUESTIONS SECTION

1-888-838-2872 between 9 am and 5 pm ET, Monday – Friday.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Actavis™

NDC 52544-239-12
Compare to the active ingredients 
in Claritin-D® 24 Hour†

Non-Drowsy*
Allergy Relief-D
Loratadine, USP 10 mg/Pseudoephedrine Sulfate, USP 240 mg
Extended-Release Tablets
Antihistamine/Nasal Decongestant

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.

Indoor & Outdoor Allergies
Allergy & Congestion
15 Extended-Release Tablets

Principal Display PanelPrincipal Display Panel

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52544-239-12EA - Each52544-239c53f54a6-e1f8-4c07-ab9e-8a3a274b4f1912018-07-03

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
52544-23952544-239-12

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
FERROSOFERRIC OXIDEXM0M87F357IACT
CANDELILLA WAXWL0328HX19IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
HYPROMELLOSE 2910 (3 MPA.S)0VUT3PMY82IACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYETHYLENE GLYCOL 8000Q662QK8M3BIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM LAURYL SULFATE368GB5141JIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML · Source PDF

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
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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075706-001LORATADINE 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…
2022-10-28 04:53 UTC2022-10A075706-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2003-02-21f41ea6bd6efb…

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
c3b0d008-7d57-463f-b18e-e1ee694cdba6e259bb5d-7845-4823-acee-da93357bf2302021-10-19WarningsExact identifier
spl id: c3b0d008-7d57-463f-b18e-e1ee694cdba6
spl set id: e259bb5d-7845-4823-acee-da93357bf230

Reported adverse events (FAERS/openFDA)#

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