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Loratadine and Pseudoephedrine Sulfate

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Loratadine and Pseudoephedrine Sulfate
Generic name
Loratadine and Pseudoephedrine Sulfate
Dosage form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Patheon Manufacturing Services LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
12
Packages
19
Data completeness
83% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Loratadine 10 mg/1 311372 View
Loratadine 5 mg/1 311372 View
Pseudoephedrine Sulfate 120 mg/1 1117562 View
Pseudoephedrine Sulfate 240 mg/1 1117562 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated, Extended Release
Route of administration
Oral
Presentations
31

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
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
Application number
076557
Application type
ANDA · Abbreviated New Drug Application
Approval date
September 22, 2004
Sponsor
SUN PHARM INDS LTD
Products on application
1
Submissions recorded
4
Products approved under application 076557.
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
Most recent submissions on application 076557.
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 Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20230823). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20230823 HUMAN OTC DRUG · 20211221 HUMAN OTC DRUG · 20180412

Indications and Usage

openFDA Drug Labeling

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 through the nose

Purpose

openFDA Drug Labeling

Active ingredients (in each tablet) Purpose Loratadine, USP 10 mg Antihistamine Pseudoephedrine sulfate, USP 240 mg Nasal decongestant

Dosage and Administration

openFDA Drug Labeling

DIRECTIONS • 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

Warnings

openFDA Drug Labeling

Warnings 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 Labeling

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

openFDA Drug Labeling

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.

Stop Use

openFDA Drug Labeling

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

Active Ingredient

openFDA Drug Labeling

Active ingredients (in each tablet) Purpose Loratadine, USP 10 mg Antihistamine Pseudoephedrine sulfate, USP 240 mg Nasal decongestant

Adverse event reports

Source: openFDA FAERS
114,194
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed 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.

Recalls

Source: FDA Enforcement
Drug recall enforcement reports associated with this product.
Classification Reported Firm Reason Status
Class III November 3, 2021 SUN PHARMACEUTICAL INDUSTRIES INC Failed Moisture Limits Terminated
Class II April 30, 2014 Ohm Laboratories, Inc. Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg. Terminated

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
46122-167-52 46122-167 Amerisource Bergen 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (46122-167-52) November 17, 2004
37808-427-69 37808-427 HEB 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (37808-427-69) February 1, 2018
37808-724-69 37808-724 HEB 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (37808-724-69) February 1, 2018
0904-5833-15 0904-5833 Major Pharmaceuticals 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0904-5833-15) November 17, 2004
0904-5833-48 0904-5833 Major Pharmaceuticals 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0904-5833-48) November 17, 2004
41250-724-52 41250-724 Meijer Distribution, Inc. 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (41250-724-52) November 17, 2004
41250-724-69 41250-724 Meijer Distribution, Inc. 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (41250-724-69) November 17, 2004
63552-039-01 63552-039 Patheon Manufacturing Services LLC 25100 TABLET, FILM COATED, EXTENDED RELEASE in 1 DRUM (63552-039-01) December 1, 2009
63552-040-01 63552-040 Patheon Manufacturing Services LLC 16800 TABLET, FILM COATED, EXTENDED RELEASE in 1 DRUM (63552-040-01) December 1, 2009
56062-724-15 56062-724 Publix Super Markets Inc 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (56062-724-15) November 17, 2004
56062-724-69 56062-724 Publix Super Markets Inc 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (56062-724-69) November 17, 2004
49348-543-01 49348-543 STRATEGIC SOURCING SERVICES 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (49348-543-01) November 17, 2004
49348-543-57 49348-543 STRATEGIC SOURCING SERVICES 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (49348-543-57) November 17, 2004
21130-724-15 21130-724 Safeway Inc. 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (21130-724-15) November 17, 2004
21130-724-69 21130-724 Safeway Inc. 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (21130-724-69) November 17, 2004
62011-0071-1 62011-0071 Strategic Sourcing Services LLC 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (62011-0071-1) November 17, 2004
62011-0071-2 62011-0071 Strategic Sourcing Services LLC 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (62011-0071-2) June 6, 2017
30142-724-15 30142-724 The Kroger Company 15 BLISTER PACK in 1 CARTON (30142-724-15) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK November 17, 2004
30142-724-69 30142-724 The Kroger Company 10 BLISTER PACK in 1 CARTON (30142-724-69) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK November 17, 2004
46122-167 46122-167 Amerisource Bergen — November 17, 2004
37808-427 37808-427 HEB — February 1, 2018
37808-724 37808-724 HEB — February 1, 2018
0904-5833 0904-5833 Major Pharmaceuticals — November 17, 2004
41250-724 41250-724 Meijer Distribution, Inc. — November 17, 2004
63552-039 63552-039 Patheon Manufacturing Services LLC — December 1, 2009
63552-040 63552-040 Patheon Manufacturing Services LLC — December 1, 2009
56062-724 56062-724 Publix Super Markets Inc — November 17, 2004
49348-543 49348-543 STRATEGIC SOURCING SERVICES — November 17, 2004
21130-724 21130-724 Safeway Inc. — November 17, 2004
62011-0071 62011-0071 Strategic Sourcing Services LLC — November 17, 2004
30142-724 30142-724 The Kroger Company — November 17, 2004

Sources for this page

Every dataset that contributed a fact to 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
Enforcement FDA Recall records

Generated September 25, 2026 · 12 sections on this page.