Non-Drowsy Allergy Relief — Tablet

Overview

Brand name

Non-Drowsy Allergy Relief

Generic name

loratadine tablet

Dosage form

Tablet

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Lil' Drug Store Products, Inc.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

2

NDC product codes

2

Packages

6

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
Fexofenadine Hydrochloride	180 mg/1	997501	View
Loratadine	10 mg/1	311372	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet

Route of administration

Oral

Presentations

8

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
Histamine H1 Receptor Antagonists [MoA]	MoA	All 136 members
Histamine-1 Receptor Antagonist [EPC]	EPC	All 134 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

076471

Application type

ANDA · Abbreviated New Drug Application

Approval date

February 14, 2006

Sponsor

APOTEX

Products on application

1

Submissions recorded

1

Products approved under application 076471.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
076471-001	LORATADINE	TABLET		LORATADINE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 076471.
Type	No.	Action	Status	Date	Review
Original application	1		Approved	February 14, 2006	—

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250801). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250801 HUMAN OTC DRUG · 20230817

Indications and Usage

openFDA Drug Labeling

Uses Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies runny nose itchy, watery eyes sneezing itching of the nose or throat

Purpose

openFDA Drug Labeling

Purpose Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

Warnings

openFDA Drug Labeling

Warnings Warnings Do not use Do not use if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. You may report side effects to 1-888-952-0050. If pregnant or breast-feeding If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. Keep out of reach of children. In case of overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

Do Not Use

openFDA Drug Labeling

Do not use Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have Ask a doctor before use if you have 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 Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. You may report side effects to 1-888-952-0050.

Active Ingredient

openFDA Drug Labeling

Active ingredient Active ingredient (in each tablet) Loratadine 10 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
66715-8815-6	66715-8815	Lil' Drug Store Products, Inc.	1 BLISTER PACK in 1 CARTON (66715-8815-6) / 6 TABLET in 1 BLISTER PACK	May 6, 2022
11673-621-01	11673-621	TARGET CORPORATION	1 BOTTLE in 1 CARTON (11673-621-01) / 150 TABLET in 1 BOTTLE	August 1, 2025
11673-621-15	11673-621	TARGET CORPORATION	3 BLISTER PACK in 1 CARTON (11673-621-15) / 5 TABLET in 1 BLISTER PACK	August 1, 2025
11673-621-30	11673-621	TARGET CORPORATION	1 BOTTLE in 1 CARTON (11673-621-30) / 30 TABLET in 1 BOTTLE	August 1, 2025
11673-621-50	11673-621	TARGET CORPORATION	150 TABLET in 1 BOTTLE (11673-621-50)	August 1, 2025
11673-621-70	11673-621	TARGET CORPORATION	1 BOTTLE in 1 CARTON (11673-621-70) / 70 TABLET in 1 BOTTLE	August 1, 2025
66715-8815	66715-8815	Lil' Drug Store Products, Inc.	—	May 6, 2022
11673-621	11673-621	TARGET CORPORATION	—	August 1, 2025

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.