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Loratadine Allergy Relief
Loratadine · Tablet
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 Allergy Relief
Generic name
Loratadine
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
A-S Medication Solutions
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
15
Packages
60
Data completeness
82%
of corroborating sources present
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Loratadine | 10 mg/1 | 311372 | View |
Forms, strengths and routes
Source: NDC DirectoryDosage form
Tablet
Route of administration
Oral
Presentations
75
Regulatory status
Source: Drugs@FDANDC DirectoryApplication number
076134
Application type
ANDA · Abbreviated New Drug Application
Approval date
August 18, 2003
Sponsor
SUN PHARM INDS LTD
Products on application
1
Submissions recorded
4
| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 076134-001 | LORATADINE | TABLET | LORATADINE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 19 | Labeling | Approved | March 24, 2009 | — |
| Supplement | 8 | Labeling | Approved | April 16, 2007 | — |
| Supplement | 15 | Manufacturing (CMC) | Approved | March 23, 2007 | — |
| Original application | 1 | Approved | August 18, 2003 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240403). This is the manufacturer's labelling text, not a summary and not advice.
HUMAN OTC DRUG · 20240403 HUMAN OTC DRUG · 20240103 HUMAN OTC DRUG · 20180914 HUMAN OTC DRUG · 20180829
Indications and Usage
openFDA Drug LabelingUSE(S) 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 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
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 LabelingActive ingredient (in each tablet) Loratadine, USP 10 mg
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Loratadine 10 mg Tablet NDC 63629-7772-1: 20 Tablets in a BOTTLE NDC 63629-7772-2: 30 Tablets in a BOTTLE NDC 63629-7772-3: 60 Tablets in a BOTTLE NDC 63629-7772-4: 14 Tablets in a BOTTLE NDC 63629-7772-5: 10 Tablets in a BOTTLE NDC 63629-7772-6: 90 Tablets in a BOTTLE NDC 63629-7772-7: 28 Tablets in a BOTTLE NDC 63629-7772-8: 15 Tablets in a BOTTLE NDC 63629-7772-9: 100 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Adverse event reports
Source: openFDA FAERS114,194
FAERS reports mentioning this drug
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| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-2387-0 | 50090-2387 | A-S Medication Solutions | 30 TABLET in 1 BLISTER PACK (50090-2387-0) | November 1, 2017 |
| 50090-7507-0 | 50090-7507 | A-S Medication Solutions | 10 TABLET in 1 BOTTLE (50090-7507-0) | February 18, 2025 |
| 50090-7507-4 | 50090-7507 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-7507-4) | February 18, 2025 |
| 50090-7507-5 | 50090-7507 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7507-5) | February 18, 2025 |
| 50090-7508-4 | 50090-7508 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7508-4) | February 18, 2025 |
| 76420-330-01 | 76420-330 | Asclemed USA, Inc. | 100 TABLET in 1 BOTTLE (76420-330-01) | April 19, 2025 |
| 76420-330-03 | 76420-330 | Asclemed USA, Inc. | 300 TABLET in 1 BOTTLE (76420-330-03) | April 19, 2025 |
| 76420-330-05 | 76420-330 | Asclemed USA, Inc. | 500 TABLET in 1 BOTTLE (76420-330-05) | April 19, 2025 |
| 76420-330-10 | 76420-330 | Asclemed USA, Inc. | 10 TABLET in 1 BOTTLE (76420-330-10) | April 19, 2025 |
| 76420-330-11 | 76420-330 | Asclemed USA, Inc. | 10 TABLET in 1 BLISTER PACK (76420-330-11) | April 19, 2025 |
| 76420-330-20 | 76420-330 | Asclemed USA, Inc. | 20 TABLET in 1 BOTTLE (76420-330-20) | May 21, 2025 |
| 76420-330-30 | 76420-330 | Asclemed USA, Inc. | 30 TABLET in 1 BOTTLE (76420-330-30) | April 19, 2025 |
| 76420-330-31 | 76420-330 | Asclemed USA, Inc. | 30 TABLET in 1 BLISTER PACK (76420-330-31) | April 19, 2025 |
| 76420-330-60 | 76420-330 | Asclemed USA, Inc. | 60 TABLET in 1 BOTTLE (76420-330-60) | April 19, 2025 |
| 76420-330-90 | 76420-330 | Asclemed USA, Inc. | 90 TABLET in 1 BOTTLE (76420-330-90) | April 19, 2025 |
| 63629-7772-1 | 63629-7772 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (63629-7772-1) | July 30, 2018 |
| 63629-7772-2 | 63629-7772 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (63629-7772-2) | July 2, 2018 |
| 63629-7772-3 | 63629-7772 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (63629-7772-3) | November 22, 2019 |
| 63629-7772-4 | 63629-7772 | Bryant Ranch Prepack | 14 TABLET in 1 BOTTLE (63629-7772-4) | December 11, 2018 |
| 63629-7772-5 | 63629-7772 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (63629-7772-5) | July 5, 2018 |
| 63629-7772-6 | 63629-7772 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (63629-7772-6) | July 5, 2018 |
| 63629-7772-7 | 63629-7772 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (63629-7772-7) | April 3, 2024 |
| 63629-7772-8 | 63629-7772 | Bryant Ranch Prepack | 15 TABLET in 1 BOTTLE (63629-7772-8) | April 3, 2024 |
| 63629-7772-9 | 63629-7772 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (63629-7772-9) | June 21, 2019 |
| 71335-0100-1 | 71335-0100 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-0100-1) | February 12, 2018 |
| 71335-0100-2 | 71335-0100 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-0100-2) | February 23, 2018 |
| 71335-0100-3 | 71335-0100 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-0100-3) | December 27, 2021 |
| 71335-0100-4 | 71335-0100 | Bryant Ranch Prepack | 14 TABLET in 1 BOTTLE (71335-0100-4) | December 27, 2021 |
| 71335-0100-5 | 71335-0100 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-0100-5) | February 20, 2018 |
| 71335-0100-6 | 71335-0100 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-0100-6) | February 9, 2018 |
| 71335-0100-7 | 71335-0100 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-0100-7) | April 5, 2024 |
| 71335-0100-8 | 71335-0100 | Bryant Ranch Prepack | 15 TABLET in 1 BOTTLE (71335-0100-8) | April 5, 2024 |
| 71335-0100-9 | 71335-0100 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-0100-9) | April 5, 2024 |
| 53943-975-30 | 53943-975 | DISCOUNT DRUG MART | 30 TABLET in 1 BLISTER PACK (53943-975-30) | November 1, 2017 |
| 53943-975-60 | 53943-975 | DISCOUNT DRUG MART | 60 TABLET in 1 BOTTLE (53943-975-60) | November 1, 2017 |
| 37808-529-01 | 37808-529 | HEB | 100 TABLET in 1 BOTTLE (37808-529-01) | February 1, 2018 |
| 37808-529-11 | 37808-529 | HEB | 1 BLISTER PACK in 1 CARTON (37808-529-11) / 10 TABLET in 1 BLISTER PACK | February 1, 2018 |
| 37808-529-31 | 37808-529 | HEB | 30 BLISTER PACK in 1 CARTON (37808-529-31) / 1 TABLET in 1 BLISTER PACK | February 1, 2018 |
| 71141-132-32 | 71141-132 | LIDL US, LLC | 1 BLISTER PACK in 1 CARTON (71141-132-32) / 10 TABLET in 1 BLISTER PACK | September 1, 2017 |
| 10135-763-03 | 10135-763 | Marlex Pharmaceuticals, Inc. | 300 TABLET in 1 BOTTLE (10135-763-03) | October 1, 2022 |
| 10135-763-30 | 10135-763 | Marlex Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE (10135-763-30) | October 1, 2022 |
| 10135-763-90 | 10135-763 | Marlex Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE (10135-763-90) | October 1, 2022 |
| 51660-526-01 | 51660-526 | OHM LABORATORIES INC. | 100 TABLET in 1 BOTTLE (51660-526-01) | November 1, 2017 |
| 51660-526-05 | 51660-526 | OHM LABORATORIES INC. | 500 TABLET in 1 BOTTLE (51660-526-05) | November 1, 2017 |
| 51660-526-11 | 51660-526 | OHM LABORATORIES INC. | 10 TABLET in 1 BLISTER PACK (51660-526-11) | November 1, 2017 |
| 51660-526-30 | 51660-526 | OHM LABORATORIES INC. | 30 TABLET in 1 BOTTLE (51660-526-30) | February 1, 2019 |
| 51660-526-31 | 51660-526 | OHM LABORATORIES INC. | 30 TABLET in 1 BLISTER PACK (51660-526-31) | November 1, 2017 |
| 51660-526-53 | 51660-526 | OHM LABORATORIES INC. | 300 TABLET in 1 BOTTLE (51660-526-53) | November 1, 2017 |
| 55289-728-15 | 55289-728 | PD-Rx Pharmaceuticals, Inc. | 15 TABLET in 1 BOTTLE, PLASTIC (55289-728-15) | March 27, 2021 |
| 55289-728-20 | 55289-728 | PD-Rx Pharmaceuticals, Inc. | 20 TABLET in 1 BOTTLE, PLASTIC (55289-728-20) | March 27, 2021 |
| 55289-728-60 | 55289-728 | PD-Rx Pharmaceuticals, Inc. | 60 TABLET in 1 BOTTLE, PLASTIC (55289-728-60) | January 18, 2023 |
| 55289-728-90 | 55289-728 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (55289-728-90) | April 6, 2018 |
| 63187-100-10 | 63187-100 | Proficient Rx LP | 10 TABLET in 1 BOTTLE (63187-100-10) | January 1, 2019 |
| 63187-100-20 | 63187-100 | Proficient Rx LP | 20 TABLET in 1 BOTTLE (63187-100-20) | January 1, 2019 |
| 63187-100-30 | 63187-100 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (63187-100-30) | January 1, 2019 |
| 63187-100-90 | 63187-100 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (63187-100-90) | October 10, 2024 |
| 67091-245-10 | 67091-245 | WinCo Foods, LLC | 10 BLISTER PACK in 1 CARTON (67091-245-10) / 1 TABLET in 1 BLISTER PACK | January 8, 2015 |
| 67091-246-30 | 67091-246 | WinCo Foods, LLC | 30 BLISTER PACK in 1 CARTON (67091-246-30) / 1 TABLET in 1 BLISTER PACK | January 8, 2015 |
| 73581-230-01 | 73581-230 | YYBA CORP | 100 TABLET in 1 BOTTLE (73581-230-01) | April 15, 2022 |
| 73581-230-36 | 73581-230 | YYBA CORP | 365 TABLET in 1 BOTTLE (73581-230-36) | April 15, 2022 |
| 50090-2387 | 50090-2387 | A-S Medication Solutions | — | November 1, 2017 |
| 50090-7507 | 50090-7507 | A-S Medication Solutions | — | October 1, 2022 |
| 50090-7508 | 50090-7508 | A-S Medication Solutions | — | October 1, 2022 |
| 76420-330 | 76420-330 | Asclemed USA, Inc. | — | November 1, 2017 |
| 63629-7772 | 63629-7772 | Bryant Ranch Prepack | — | November 1, 2017 |
| 71335-0100 | 71335-0100 | Bryant Ranch Prepack | — | November 1, 2017 |
| 53943-975 | 53943-975 | DISCOUNT DRUG MART | — | November 1, 2017 |
| 37808-529 | 37808-529 | HEB | — | February 1, 2018 |
| 71141-132 | 71141-132 | LIDL US, LLC | — | September 1, 2017 |
| 10135-763 | 10135-763 | Marlex Pharmaceuticals, Inc. | — | October 1, 2022 |
| 55289-728 | 55289-728 | PD-Rx Pharmaceuticals, Inc. | — | November 1, 2017 |
| 63187-100 | 63187-100 | Proficient Rx LP | — | August 28, 2003 |
| 67091-245 | 67091-245 | WinCo Foods, LLC | — | August 28, 2003 |
| 67091-246 | 67091-246 | WinCo Foods, LLC | — | August 28, 2003 |
| 73581-230 | 73581-230 | YYBA CORP | — | April 15, 2022 |
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 · 9 sections on this page.