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loratadine and pseudoephedrine
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Adrenergic alpha-Agonists [MoA] | MoA | All 85 members |
| alpha-Adrenergic Agonist [EPC] | EPC | All 85 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | TABLET, EXTENDED RELEASE | LORATADINE; PSEUDOEPHEDRINE SULFATE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 15 | Labeling | Approved | June 29, 2010 | — |
| Supplement | 6 | Labeling | Approved | September 20, 2005 | — |
| Supplement | 2 | Labeling | Approved | April 13, 2005 | — |
| Original application | 1 | Approved | September 22, 2004 | — |
Review documents
- 0 · Original application · February 15, 2011
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20220509). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses • 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 through the nose
Purpose
openFDA Drug LabelingActive ingredients (in each tablet) Purpose Loratadine, USP 10 mg Antihistamine Pseudoephedrine sulfate, USP 240 mg Nasal decongestant
Dosage and Administration
openFDA Drug LabelingDirections • 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
Warnings
openFDA Drug LabelingWARNINGS 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. 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. When using this product do not take more than directed. Taking more than directed may cause drowsiness. 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 If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Do Not Use
openFDA Drug LabelingDo 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.
Ask a Doctor
openFDA Drug LabelingAsk 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.
Stop Use
openFDA Drug LabelingStop 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
Active Ingredient
openFDA Drug LabelingActive ingredients (in each tablet) Purpose Loratadine, USP 10 mg Antihistamine Pseudoephedrine sulfate, USP 240 mg Nasal decongestant
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: LORATADINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 46122-383-22 | 46122-383 | AMERISOURCE BERGEN | 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (46122-383-22) | August 2, 2017 |
| 51660-491-69 | 51660-491 | Ohm Laboratories Inc. | 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51660-491-69) | January 15, 2020 |
| 51660-724-04 | 51660-724 | Ohm Laboratories Inc. | 3 BLISTER PACK in 1 CARTON (51660-724-04) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | November 17, 2004 |
| 51660-724-15 | 51660-724 | Ohm Laboratories Inc. | 1 BLISTER PACK in 1 CARTON (51660-724-15) / 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | November 17, 2004 |
| 51660-724-69 | 51660-724 | Ohm Laboratories Inc. | 1 BLISTER PACK in 1 CARTON (51660-724-69) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | November 17, 2004 |
| 63187-305-10 | 63187-305 | Proficient Rx LP | 1 BLISTER PACK in 1 CARTON (63187-305-10) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 1, 2015 |
| 11822-9990-0 | 11822-9990 | Rite Aid | 1 BLISTER PACK in 1 CARTON (11822-9990-0) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | November 17, 2004 |
| 11822-9990-5 | 11822-9990 | Rite Aid | 1 BLISTER PACK in 1 CARTON (11822-9990-5) / 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | November 17, 2004 |
| 70677-1018-1 | 70677-1018 | STRATEGIC SOURCING SERVICES LLC | 1 BLISTER PACK in 1 CARTON (70677-1018-1) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 10, 2023 |
| 70677-1018-2 | 70677-1018 | STRATEGIC SOURCING SERVICES LLC | 1 BLISTER PACK in 1 CARTON (70677-1018-2) / 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 10, 2023 |
| 85766-048-10 | 85766-048 | Sportpharm LLC | 1 BLISTER PACK in 1 CARTON (85766-048-10) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 2, 2025 |
| 46122-383 | 46122-383 | AMERISOURCE BERGEN | — | August 2, 2017 |
| 51660-491 | 51660-491 | Ohm Laboratories Inc. | — | November 17, 2004 |
| 51660-724 | 51660-724 | Ohm Laboratories Inc. | — | November 17, 2004 |
| 63187-305 | 63187-305 | Proficient Rx LP | — | November 17, 2004 |
| 11822-9990 | 11822-9990 | Rite Aid | — | November 17, 2004 |
| 70677-1018 | 70677-1018 | STRATEGIC SOURCING SERVICES LLC | — | August 10, 2023 |
| 85766-048 | 85766-048 | Sportpharm LLC | — | November 17, 2004 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 10 sections on this page.