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Allervarx

Loratadine · Tablet, Orally Disintegrating

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

Allervarx

Generic name

Loratadine

Dosage form

Tablet, Orally Disintegrating

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Innovus Pharmaceuticals, Inc.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

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
Loratadine	5 mg/1	311372	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet, Orally Disintegrating

Route of administration

Oral

Presentations

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

213294

Application type

ANDA · Abbreviated New Drug Application

Approval date

October 30, 2020

Sponsor

INSTAPILL

Products on application

Submissions recorded

Products approved under application 213294.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
213294-001	LORATADINE	TABLET, ORALLY DISINTEGRATING		LORATADINE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 213294.
Type	No.	Action	Status	Date	Review
Original application	1		Approved	October 30, 2020	Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20241227). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20241227 HUMAN OTC DRUG · 20241227

Indications and Usage

openFDA Drug Labeling

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 Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

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.

Ask a Doctor

openFDA Drug Labeling

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 an allergic reaction to this product occurs. Seek medical help right away.

Active Ingredient

openFDA Drug Labeling

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
57483-950-10	57483-950	Innovus Pharmaceuticals, Inc.	3 BLISTER PACK in 1 CARTON (57483-950-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	May 30, 2022
57483-955-05	57483-955	Innovus Pharmaceuticals, Inc.	3 BLISTER PACK in 1 CARTON (57483-955-05) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	August 1, 2022
57483-950	57483-950	Innovus Pharmaceuticals, Inc.	—	May 30, 2022
57483-955	57483-955	Innovus Pharmaceuticals, Inc.	—	June 4, 2022

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 · 9 sections on this page.