SinuLief 10 mg/1

Loratadine · TABLET · RoseWell Pharmaceuticals LLC

No Recall History

Plain English

SinuLief is a tablet containing loratadine at 10 mg/1, taken oral. Manufactured by RoseWell Pharmaceuticals LLC.

Key Facts

Brand Name: SinuLief
Generic Name: Loratadine
NDC Code (Product): 85510-101
Manufacturer: RoseWell Pharmaceuticals LLC
Strength: 10 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: M012
Marketing Start: 04/18/2025

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

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

Dosage & Administration

Directions

Warnings

Drug label_only 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. I pregnant or breast-feeding ask a health professional before use. Keep out of reach of children In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

Frequently Asked Questions

What is SinuLief used for?

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

Is SinuLief a controlled substance?

SinuLief is not classified as a controlled substance by the DEA.

What is the generic name for SinuLief?

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

What is the NDC code for SinuLief 10 mg/1?

The NDC (National Drug Code) for SinuLief 10 mg/1 is 85510-101, listed by RoseWell Pharmaceuticals LLC.

Product NDC

85510-101

Package NDC

85510-101-01

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)