Loratadine Tablet
FDA Label NDC 70677-1240
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services, Llc for the product Loratadine (NDC 70677-1240). 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 drug facts, active ingredient (in each tablet) loratadine 10 mg, purpose antihistamine, usestemporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, water eyes • sneezing • itching of the nose or throat, warningsdo not useif you have ever had an allergic reaction to this product or any of its ingredients, ask a doctor before use if you haveliver or kidney disease. your doctor should determine if you need a different dose., when using this productdo not take more than directed. taking more than directed may cause drowsiness., stop use and ask a doctorif an allergic reaction to this product occurs. seek medical help right away., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet) Loratadine 10 Mg
Purpose Antihistamine
Usestemporarily Relieves These Symptoms Due To Hay Fever Or Other Upper Respiratory Allergies: • Runny Nose • Itchy, Water Eyes • Sneezing • Itching Of The Nose Or Throat
Warningsdo Not Useif You Have Ever Had An Allergic Reaction To This Product Or Any Of Its Ingredients
Ask A Doctor Before Use If You Haveliver Or Kidney Disease. Your Doctor Should Determine If You Need A Different Dose.
When Using This Productdo Not Take More Than Directed. Taking More Than Directed May Cause Drowsiness.
Stop Use And Ask A Doctorif 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).
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
Other Information • Store Between 20º To 25ºc (68º To 77ºf)
Inactive Ingredients Corn Starch, Lactose Monohydrate, Magnesium Stearate, Povidone
Questions Or Comments? 833-358-6431
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