Loratadine antihistamine 10 mg/1

Loratadine · TABLET · Aphena Pharma Solutions - Tennessee, LLC

No Recall History

Plain English

Loratadine antihistamine is a tablet containing loratadine at 10 mg/1, taken oral. Manufactured by Aphena Pharma Solutions - Tennessee, LLC.

Key Facts

Brand Name: Loratadine antihistamine
Generic Name: Loratadine
NDC Code (Product): 43353-259
Manufacturer: Aphena Pharma Solutions - Tennessee, LLC
Strength: 10 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: ANDA076301
Marketing Start: 10/15/2008

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective3,545 reports

fatigue3,226 reports

nausea2,695 reports

dyspnoea2,432 reports

headache2,406 reports

diarrhoea2,365 reports

off label use2,229 reports

dizziness2,064 reports

pain1,979 reports

rash1,617 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 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. 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)

Frequently Asked Questions

What is Loratadine antihistamine used for?

Loratadine antihistamine contains Loratadine. It is a tablet taken oral. Consult your doctor for specific uses.

Is Loratadine antihistamine a controlled substance?

Loratadine antihistamine is not classified as a controlled substance by the DEA.

What is the generic name for Loratadine antihistamine?

The generic name for Loratadine antihistamine is Loratadine. There are 12 other brand versions of Loratadine.

What is the NDC code for Loratadine antihistamine 10 mg/1?

The NDC (National Drug Code) for Loratadine antihistamine 10 mg/1 is 43353-259, listed by Aphena Pharma Solutions - Tennessee, LLC.

Product NDC

43353-259

Package NDC

43353-259-09

Other Loratadine Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)