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Loratadine and Pseudoephedrine Sulfate

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, Extended Release
Route
—
Marketing category
DRUG FOR FURTHER PROCESSING · BULK API
Labeler
Actavis Pharma, Inc.
Product type
Drug For Further Processing
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
3
Packages
4
Data completeness
76% 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
Pseudoephedrine Sulfate 240 mg/1 1117562 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Extended Release
Route of administration
—
Presentations
7

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 20250414). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250414

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.

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
62037-605-08 62037-605 Actavis Pharma, Inc. 10638 TABLET, EXTENDED RELEASE in 1 BOX (62037-605-08) February 21, 2003
55370-790-00 55370-790 Patheon Puerto Rico, Inc. 16800 TABLET, EXTENDED RELEASE in 1 DRUM (55370-790-00) December 1, 2009
49035-488-15 49035-488 WAL-MART STORES, INC 15 TABLET, EXTENDED RELEASE in 1 CARTON (49035-488-15) June 15, 2020
49035-488-69 49035-488 WAL-MART STORES, INC 10 TABLET, EXTENDED RELEASE in 1 CARTON (49035-488-69) June 15, 2020
62037-605 62037-605 Actavis Pharma, Inc. — February 21, 2003
55370-790 55370-790 Patheon Puerto Rico, Inc. — December 1, 2009
49035-488 49035-488 WAL-MART STORES, INC — June 15, 2020

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

Generated September 25, 2026 · 11 sections on this page.