loratadine D — Tablet, Film Coated, Extended Release

Overview

Brand name

loratadine D

Generic name

loratadine, Pseudoephedrine sulfate

Dosage form

Tablet, Film Coated, Extended Release

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Sportpharm LLC

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

2

NDC product codes

2

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	5 mg/1	311372	View
Pseudoephedrine Sulfate	120 mg/1	1117562	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet, Film Coated, Extended Release

Route of administration

Oral

Presentations

6

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@FDA NDC Directory

Application number

076050

Application type

ANDA · Abbreviated New Drug Application

Approval date

January 30, 2003

Sponsor

PERRIGO PHARMA INTL

Products on application

1

Submissions recorded

5

Products approved under application 076050.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	TABLET, EXTENDED RELEASE		LORATADINE; PSEUDOEPHEDRINE SULFATE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 076050.
Type	No.	Action	Status	Date	Review
Supplement	21	Manufacturing (CMC)	Approved	October 21, 2014	—
Supplement	11	Labeling	Approved	June 21, 2005	—
Supplement	7	Labeling	Approved	September 22, 2004	—
Supplement	5	Labeling	Approved	July 28, 2004	—
Original application	1		Approved	January 30, 2003	—

Review documents

0 · Original application · March 28, 2012
0 · Original application · June 8, 2004

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260206). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260206 HUMAN OTC DRUG · 20250303

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 • 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

Purpose

openFDA Drug Labeling

Purpose Antihistamine 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 every 12 hours; not more than 2 tablets 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) Loratadine 5 mg Pseudoephedrine sulfate 120 mg

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
45802-122-46	45802-122	Padagis Israel Pharmaceuticals Ltd	10 BLISTER PACK in 1 CARTON (45802-122-46) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	April 10, 2018
45802-122-60	45802-122	Padagis Israel Pharmaceuticals Ltd	20 BLISTER PACK in 1 CARTON (45802-122-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	April 10, 2018
45802-122-65	45802-122	Padagis Israel Pharmaceuticals Ltd	30 BLISTER PACK in 1 CARTON (45802-122-65) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	April 10, 2018
85766-047-10	85766-047	Sportpharm LLC	10 BLISTER PACK in 1 CARTON (85766-047-10) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	August 2, 2025
45802-122	45802-122	Padagis Israel Pharmaceuticals Ltd	—	April 10, 2018
85766-047	85766-047	Sportpharm LLC	—	April 10, 2018

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 · 10 sections on this page.