Active Ingredient (In Each Tablet)
Loratadine 10 mg.....................................................................................................Antihistamine
Sinulief Tablet
FDA Label NDC 85510-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rosewell Pharmaceuticals Llc for the product Sinulief (NDC 85510-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor, i pregnant or breast-feeding, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - When Using
Adults and children 6 years and older 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
Dosage & Administration
Directions (Directions)
Other Information
- store between 20° to 25°C (68°-77° F)
- protect from excessive moisture
- do not use if blister unit is torn or open
- retain carton for complete product information.
Innactive Ingredients
lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate.
Questions And Comments?
Call 1-833-999-7795
Otc - Purpose
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
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 (Uses)
* Please review the disclaimer below.
