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Loratadine
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Loratadine | 5 mg/5mL | 311372 | View |
Forms, strengths and routes
Source: NDC DirectoryRegulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 077421-001 | LORATADINE | SYRUP | LORATADINE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| 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 LabelingReproduced 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.
Indications and Usage
openFDA Drug LabelingUses 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
openFDA Drug LabelingPurpose: Antihistamine
Purpose: Antihistamine
Dosage and Administration
openFDA Drug LabelingDirections 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
openFDA Drug LabelingWarnings 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
openFDA Drug LabelingDo 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 LabelingAsk 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
openFDA Drug LabelingStop 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 LabelingActive 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 LabelingHOW SUPPLIED Product: 50090-1454 NDC: 50090-1454-0 120 mL in a CARTON
Adverse event reports
Source: openFDA FAERSAttributed 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| 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
| 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.