KIRKLAND SIGNATURE ALLERCLEAR D 24 HR — Tablet, Extended Release

Overview

Brand name

KIRKLAND SIGNATURE ALLERCLEAR D 24 HR Extended Release

Generic name

loratadine and pseudoephedrine sulfate

Dosage form

Tablet, Extended Release

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Kirkland-COSTCO WHOLESALE COMPANY

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

2

NDC product codes

2

Packages

2

Data completeness

77% 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

Oral

Presentations

4

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

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

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

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
63981-138-22	63981-138	Costco Wholesale Company	15 BLISTER PACK in 1 CARTON (63981-138-22) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	October 3, 2025
63981-724-15	63981-724	Kirkland-COSTCO WHOLESALE COMPANY	1 BLISTER PACK in 1 CARTON (63981-724-15) / 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	August 25, 2017
63981-138	63981-138	Costco Wholesale Company	—	October 3, 2025
63981-724	63981-724	Kirkland-COSTCO WHOLESALE COMPANY	—	August 25, 2017

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 · 11 sections on this page.