Active Ingredient (In Each Tablet)
Loratadine USP 10 mg
Loratadine Tablet
FDA Label NDC 68788-4103
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Preferred Pharmaceuticals Inc. for the product Loratadine (NDC 68788-4103). 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, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, 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
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 (1-800-222-1222) 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
- Tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken
- store at 20° to 25°C (68° to 77°F)
- protect from excessive moisture
Inactive Ingredients
lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.
Questions Or Comments?
call 1-855-274-4122
Distributed by: AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648
Made in India
Repackaged By: Preferred Pharmaceuticals Inc.
Code: TS/DRUGS/22/2009
Package Label-Principal Display Panel - 10 Mg
NDC 68788-4103
Non-Drowsy*
Loratadine
Tablets USP 10 mg
Antihistamine
24 Hour
Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
Indoor & Outdoor
Allergies
*When taken as directed.
See Drug Facts Panel.
Preferred Pharmaceuticals Inc.
Loratadine Tablets 10mg (Loratadine Fig1)
* Please review the disclaimer below.
