Active Ingredient (In Each Tablet)
Loratadine, USP 10 mg
Loratadine
FDA Label NDC 53808-0457
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by State Of Florida Doh Central Pharmacy for the product Loratadine (NDC 53808-0457). 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), purpose, uses, how supplied, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
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
How Supplied
They are supplied by State of Florida DOH Central Pharmacy as follows:
| NDC | Strength | Quantity/Form | Color | Source Prod. Code |
| 53808-0457-1 | 10 mg | 30 Tablets in a Blister Pack | WHITE | 45802-0650 |
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.
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
- Safety sealed: do not use if the imprinted bottle seal is open or torn.
Inactive Ingredients
Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
Questions Or Comments?
1 800 719-9260
10 Mg Label
NDC 53808-0457-1 Non-Drowsy*
LORAtadine
Tablets, USP
10 mg
Antihistamine
Indoor & Outdoor Allergies
24 Hour
Relief of:
• Sneezing
• Runny Nose
• Itchy, Watery
Eyes
• Itchy Throat
or Nose
* When taken as directed.
See Drug Facts Panel.
* Please review the disclaimer below.
