Loratadine 10 mg/1
Loratadine · TABLET · Major Pharmaceuticals
Loratadine is an antihistamine tablet taken by mouth that helps relieve allergy symptoms such as sneezing, itching, watery eyes, and runny nose. It is available over-the-counter without a prescription.
Key Facts
- Brand Name
- Loratadine
- Generic Name
- Loratadine
- NDC Code (Product)
0904-7426- Manufacturer
- Major Pharmaceuticals
- Strength
- 10 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA208314
- Marketing Start
- 02/23/2024
Recall History
Ohm Laboratories, Inc.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Ohm Laboratories, Inc.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Ohm Laboratories, Inc.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Ohm Laboratories, Inc.
Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.
Aidapak Services, LLC
Labeling: Label Mixup; LORATADINE Tablet, 10 mg may be potentially mislabeled as GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: W002650, EXP: 6/5/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 05445800022, Pedigree: AD21858_4, EXP: 5/1/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003217, EXP: 6/14/2014.
Ohm Laboratories, Inc.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Ohm Laboratories, Inc.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Ohm Laboratories, Inc.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Ohm Laboratories, Inc.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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
Dosage & Administration
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
Warnings
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 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.
Frequently Asked Questions
What is Loratadine used for?
Loratadine is an antihistamine tablet taken by mouth that helps relieve allergy symptoms such as sneezing, itching, watery eyes, and runny nose. It is available over-the-counter without a prescription.
Is Loratadine a controlled substance?
Loratadine is not classified as a controlled substance by the DEA.
What is the generic name for Loratadine?
The generic name for Loratadine is Loratadine. There are 11 other brand versions of Loratadine.
What is the NDC code for Loratadine 10 mg/1?
The NDC (National Drug Code) for Loratadine 10 mg/1 is 0904-7426, listed by Major Pharmaceuticals.
Other Loratadine Brands
See all →- Gencare-Allergy Relief Loratadine Tablets, 10 mg10 mg/172090-051
- Alavert Allergy10 mg/180070-110
- Alavert Allergy10 mg/180070-120
- ValuMeds Allergy Relief Loratadine10 mg/182725-1142
- Claritin10 mg/185237-1630
- Childrens Loratadine Oral5 mg/5mL0904-6767
- Claritin5 mg/111523-0104
- loratadine10 mg/111822-0919
- Allergy Relief10 mg/121130-195
- Good Neighbor Pharmacy Childrens Loratadine5 mg/5mL24385-531
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)