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LORATADINE
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryRegulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 213294-001 | LORATADINE | TABLET, ORALLY DISINTEGRATING | LORATADINE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | October 30, 2020 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260904). 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
Purpose
openFDA Drug LabelingPurpose Antihistamine
Dosage and Administration
openFDA Drug LabelingDirections Place 1 tablet on tongue; tablet disentigrates with or without water. adults and children 6 years and over 1 tablet daily; do not use more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers who have liver or kidney disease ask a doctor
Warnings
openFDA Drug LabelingWarnings 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 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 (1-800-222-1222).
Do Not Use
openFDA Drug LabelingDo not use if you have ever had an allergic reaction to this product 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.
Stop Use
openFDA Drug LabelingStop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Active Ingredient
openFDA Drug LabelingDrug Facts Active ingredient (in each tablet) Purpose Loratadine USP, 10 mg............................................................Antihistamine 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 Warnings 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 liver or kidney disease. Your doctor should determine if you need a different dose. When using a 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. Directions place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours Children under 6 years of age ask a doctor Consumers with liver or kidney disease ask a doctor Other information Phenylketonurics: contains phenylalanine (a component of aspartame) 1.52 mg per 10 mg orally disintegrating tablet. safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally Disintegrating Tablets USP 10 mg is open or torn store between 20° to 25°C (68° to 77°F) use tablet immediately after opening individual blister FDA approved acceptance criteria for assay and organic impurities differs from USP test Inactive ingredients aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, maize starch, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate Questions or comments? Advagen - 866-488-0312 Distributed by: Advagen Pharma Ltd East Windsor, NJ 08520, USA Manufactured by: Rubicon Research Ltd., Thane 421506, India. Rev. 02, 11/24
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 |
|---|---|---|---|---|
| 72888-029-09 | 72888-029 | Advagen Pharma Limited | 1 BLISTER PACK in 1 CARTON (72888-029-09) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | September 10, 2020 |
| 72888-029-11 | 72888-029 | Advagen Pharma Limited | 3 BLISTER PACK in 1 CARTON (72888-029-11) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | September 10, 2020 |
| 59651-074-49 | 59651-074 | Aurobindo Pharma Limited | 4000 TABLET, ORALLY DISINTEGRATING in 1 BAG (59651-074-49) | April 11, 2018 |
| 62938-0004-1 | 62938-0004 | CATALENT U.K. SWINDON ZYDIS LIMITED | 3024 BLISTER PACK in 1 BOX (62938-0004-1) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | December 12, 2006 |
| 62938-0004-2 | 62938-0004 | CATALENT U.K. SWINDON ZYDIS LIMITED | 3024 BLISTER PACK in 1 BOX (62938-0004-2) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | December 12, 2006 |
| 62938-0004-3 | 62938-0004 | CATALENT U.K. SWINDON ZYDIS LIMITED | 3024 BLISTER PACK in 1 BOX (62938-0004-3) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | January 30, 2023 |
| 62938-0005-2 | 62938-0005 | CATALENT U.K. SWINDON ZYDIS LIMITED | 3024 BLISTER PACK in 1 BOX (62938-0005-2) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | November 27, 2002 |
| 62938-0005-3 | 62938-0005 | CATALENT U.K. SWINDON ZYDIS LIMITED | 3024 BLISTER PACK in 1 BOX (62938-0005-3) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | November 27, 2002 |
| 51316-502-01 | 51316-502 | CVS PHARMACY, INC | 1 BLISTER PACK in 1 CARTON (51316-502-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | December 31, 2021 |
| 51316-502-02 | 51316-502 | CVS PHARMACY, INC | 2 BLISTER PACK in 1 CARTON (51316-502-02) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | December 31, 2021 |
| 51316-502-03 | 51316-502 | CVS PHARMACY, INC | 3 BLISTER PACK in 1 CARTON (51316-502-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | December 31, 2021 |
| 51316-502-04 | 51316-502 | CVS PHARMACY, INC | 4 BLISTER PACK in 1 CARTON (51316-502-04) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | December 31, 2021 |
| 51316-502-05 | 51316-502 | CVS PHARMACY, INC | 5 BLISTER PACK in 1 CARTON (51316-502-05) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | December 31, 2021 |
| 51316-502-06 | 51316-502 | CVS PHARMACY, INC | 6 BLISTER PACK in 1 CARTON (51316-502-06) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | December 31, 2021 |
| 51316-503-01 | 51316-503 | CVS PHARMACY, INC | 1 BLISTER PACK in 1 CARTON (51316-503-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | August 8, 2021 |
| 51316-503-02 | 51316-503 | CVS PHARMACY, INC | 2 BLISTER PACK in 1 CARTON (51316-503-02) / 20 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | August 8, 2021 |
| 51316-503-03 | 51316-503 | CVS PHARMACY, INC | 3 BLISTER PACK in 1 CARTON (51316-503-03) / 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | August 8, 2021 |
| 51316-503-04 | 51316-503 | CVS PHARMACY, INC | 4 BLISTER PACK in 1 CARTON (51316-503-04) / 40 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | August 8, 2021 |
| 51316-503-05 | 51316-503 | CVS PHARMACY, INC | 5 BLISTER PACK in 1 CARTON (51316-503-05) / 50 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | August 8, 2021 |
| 51316-503-06 | 51316-503 | CVS PHARMACY, INC | 6 BLISTER PACK in 1 CARTON (51316-503-06) / 60 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | August 8, 2021 |
| 43598-707-30 | 43598-707 | Dr. Reddy's Laboratories Inc. | 3 BLISTER PACK in 1 CARTON (43598-707-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | July 1, 2023 |
| 43598-758-10 | 43598-758 | Dr. Reddy's Laboratories Inc. | 1 BLISTER PACK in 1 CARTON (43598-758-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | July 1, 2023 |
| 43598-758-30 | 43598-758 | Dr. Reddy's Laboratories Inc. | 3 BLISTER PACK in 1 CARTON (43598-758-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | July 1, 2023 |
| 11822-0558-0 | 11822-0558 | Rite Aid Corporation | 30 BLISTER PACK in 1 CARTON (11822-0558-0) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | July 17, 2020 |
| 59556-917-01 | 59556-917 | Strides Pharma Inc | 1 BLISTER PACK in 1 CARTON (59556-917-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | August 10, 2021 |
| 59556-917-02 | 59556-917 | Strides Pharma Inc | 2 BLISTER PACK in 1 CARTON (59556-917-02) / 20 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | August 10, 2021 |
| 59556-917-03 | 59556-917 | Strides Pharma Inc | 3 BLISTER PACK in 1 CARTON (59556-917-03) / 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | August 10, 2021 |
| 59556-917-04 | 59556-917 | Strides Pharma Inc | 4 BLISTER PACK in 1 CARTON (59556-917-04) / 40 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | August 10, 2021 |
| 59556-917-05 | 59556-917 | Strides Pharma Inc | 5 BLISTER PACK in 1 CARTON (59556-917-05) / 50 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | August 10, 2021 |
| 59556-917-06 | 59556-917 | Strides Pharma Inc | 6 BLISTER PACK in 1 CARTON (59556-917-06) / 60 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | August 10, 2021 |
| 72983-501-01 | 72983-501 | Tenshi Kaizen Pvt Ltd | 1 BLISTER PACK in 1 CARTON (72983-501-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | May 19, 2021 |
| 72983-501-03 | 72983-501 | Tenshi Kaizen Pvt Ltd | 3 BLISTER PACK in 1 CARTON (72983-501-03) / 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | May 19, 2021 |
| 72983-503-06 | 72983-503 | Tenshi Kaizen Pvt Ltd | 60 BLISTER PACK in 1 CARTON (72983-503-06) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | May 7, 2024 |
| 72888-029 | 72888-029 | Advagen Pharma Limited | — | September 10, 2020 |
| 59651-074 | 59651-074 | Aurobindo Pharma Limited | — | April 11, 2018 |
| 62938-0004 | 62938-0004 | CATALENT U.K. SWINDON ZYDIS LIMITED | — | December 12, 2006 |
| 62938-0005 | 62938-0005 | CATALENT U.K. SWINDON ZYDIS LIMITED | — | November 27, 2002 |
| 51316-502 | 51316-502 | CVS PHARMACY, INC | — | December 31, 2021 |
| 51316-503 | 51316-503 | CVS PHARMACY, INC | — | August 8, 2021 |
| 43598-707 | 43598-707 | Dr. Reddy's Laboratories Inc. | — | May 19, 2021 |
| 43598-758 | 43598-758 | Dr. Reddy's Laboratories Inc. | — | May 19, 2021 |
| 11822-0558 | 11822-0558 | Rite Aid Corporation | — | July 17, 2020 |
| 59556-917 | 59556-917 | Strides Pharma Inc | — | August 10, 2021 |
| 72983-501 | 72983-501 | Tenshi Kaizen Pvt Ltd | — | May 19, 2021 |
| 72983-503 | 72983-503 | Tenshi Kaizen Pvt Ltd | — | May 7, 2024 |
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.