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Loratadine

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
Loratadine
Generic name
Loratadine
Dosage form
Solution
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Lannett Company, Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
13
Packages
15
Data completeness
82% 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/5mL 311372 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution
Route of administration
Oral
Presentations
28

Regulatory status

Source: Drugs@FDANDC Directory
Application number
077421
Application type
ANDA · Abbreviated New Drug Application
Approval date
June 29, 2006
Sponsor
LANNETT CO INC
Products on application
1
Submissions recorded
3
Products approved under application 077421.
Product Trade name Form Strength Ingredient Status TE Flags
077421-001 LORATADINE SYRUP LORATADINE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 077421.
Type No. Action Status Date Review
Supplement 8 Manufacturing (CMC) Approved November 7, 2014 —
Supplement 4 Labeling Approved August 12, 2014 —
Original application 1 Approved June 29, 2006 —

Review documents

  • 0 · Original application · July 13, 2006

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260226). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260226 HUMAN OTC DRUG · 20231209

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

Uses relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Purpose: Antihistamine

Purpose: Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions adults and children 6 years and over 2 teaspoonfuls (TSP) daily; do not take more than 2 teaspoonfuls (TSP) in 24 hours children 2 to under 6 years of age 1 teaspoonful (TSP) daily; do not take more than 1 teaspoonful (TSP) in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Directions adults and children 6 years and over 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information Safety sealed. Do not use if imprinted seal around cap is broken or missing Store between 20° to 25°C (68° to 77°F)

Warnings Do not use if you have ever had allergic reaction to this product or any of it's ingredients 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 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. 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.

Warnings Severe Allergy Warning : Get emergency help immediately if you have hives along with any of the following symptoms: trouble swallowing dizziness or loss of consciousness swelling of tongue swelling in or around mouth trouble speaking drooling wheezing or problems breathing These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately . Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. Not a Substitute for Epinephrine . If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times. Do not use - to prevent hives from any known cause such as: foods insects stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. - if you have ever had an allergic reaction to this product (loratadine) or any of its ingredients Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. hives that are an unusual color, look bruised or blistered hives that do not itch 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. Get medical help right away symptoms don’t improve after 3 days of treatment the hives have lasted more than 6 weeks 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.

Do not use - to prevent hives from any known cause such as: foods insects stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. - if you have ever had an allergic reaction to this product (loratadine) 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.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. hives that are an unusual color, look bruised or blistered hives that do not itch

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Stop use and ask a doctor if an allergic reaction to this product occurs. Get medical help right away symptoms don’t improve after 3 days of treatment the hives have lasted more than 6 weeks

Active Ingredient

openFDA Drug Labeling

Active Ingredient: Loratadine 5 mg (in each 5 mL(teaspoonful)(TSP))

Active Ingredient: Loratadine 5 mg (in each 5 mL(teaspoonful(tsp)))

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Product: 50090-1454 NDC: 50090-1454-0 120 mL in a CARTON

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
50090-1454-0 50090-1454 A-S Medication Solutions 120 mL in 1 CARTON (50090-1454-0) November 28, 2014
58602-423-11 58602-423 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-423-11) / 60 mL in 1 BOTTLE June 29, 2018
58602-423-24 58602-423 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-423-24) / 120 mL in 1 BOTTLE June 29, 2018
21130-042-24 21130-042 Better Living Brands LLC 1 BOTTLE in 1 CARTON (21130-042-24) / 120 mL in 1 BOTTLE September 25, 2023
68001-449-98 68001-449 BluePoint Laboratories 1 BOTTLE in 1 CARTON (68001-449-98) / 120 mL in 1 BOTTLE July 31, 2020
69230-322-12 69230-322 Camber Consumer Care Inc 1 BOTTLE in 1 CARTON (69230-322-12) / 120 mL in 1 BOTTLE May 7, 2021
69230-322-24 69230-322 Camber Consumer Care Inc 1 BOTTLE in 1 CARTON (69230-322-24) / 240 mL in 1 BOTTLE May 7, 2021
70000-0125-1 70000-0125 Cardinal Health, 110 dba LEADER 1 BOTTLE in 1 CARTON (70000-0125-1) / 118 mL in 1 BOTTLE October 24, 2016
30142-062-24 30142-062 KROGER COMPANY 1 BOTTLE in 1 CARTON (30142-062-24) / 120 mL in 1 BOTTLE March 15, 2021
54838-554-40 54838-554 Lannett Company, Inc. 120 mL in 1 CARTON (54838-554-40) November 24, 2010
54838-558-40 54838-558 Lannett Company, Inc. 120 mL in 1 CARTON (54838-558-40) November 24, 2010
68071-4451-4 68071-4451 NuCare Pharmaceuticals,Inc. 120 mL in 1 BOX (68071-4451-4) May 25, 2018
70677-1057-1 70677-1057 STRATEGIC SOURCING SERVICES LLC 1 BOTTLE in 1 CARTON (70677-1057-1) / 120 mL in 1 BOTTLE August 1, 2023
0363-0771-01 0363-0771 WALGREEN COMPANY 1 BOTTLE in 1 CARTON (0363-0771-01) / 240 mL in 1 BOTTLE April 19, 2023
0363-0771-08 0363-0771 WALGREEN COMPANY 1 BOTTLE in 1 CARTON (0363-0771-08) / 120 mL in 1 BOTTLE April 19, 2023
50090-1454 50090-1454 A-S Medication Solutions — November 24, 2010
17856-0557 17856-0557 ATLANTIC BIOLOGICALS CORP. — February 13, 2019
58602-423 58602-423 Aurohealth LLC — June 29, 2018
21130-042 21130-042 Better Living Brands LLC — September 25, 2023
68001-449 68001-449 BluePoint Laboratories — July 31, 2020
69230-322 69230-322 Camber Consumer Care Inc — May 7, 2021
70000-0125 70000-0125 Cardinal Health, 110 dba LEADER — August 20, 2004
30142-062 30142-062 KROGER COMPANY — March 15, 2021
54838-554 54838-554 Lannett Company, Inc. — November 24, 2010
54838-558 54838-558 Lannett Company, Inc. — November 24, 2010
68071-4451 68071-4451 NuCare Pharmaceuticals,Inc. — November 24, 2010
70677-1057 70677-1057 STRATEGIC SOURCING SERVICES LLC — August 1, 2023
0363-0771 0363-0771 WALGREEN COMPANY — April 19, 2023

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.