Active Ingredient (In Each Tablet)
Loratadine 10 mg
Loratadine Tablet
FDA Label NDC 0904-7511
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Loratadine (NDC 0904-7511). 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, do not use, 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
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. (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
- do not use if printed foil under cap is broken or missing
- store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
lactose monohydrate, magnesium stearate, povidone, pregelatinized starch
Questions Or Comments?
1-800-719-9260
Other Safety Information
This Unit Dose package is not child resistant and is intended for Institutional Use Only.
Gluten Free
The drug product contained in this package is from NDC # 0904-6852, Major® Pharmaceuticals
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268 USA
LBLN0296-01
Rev. 03/25 | M-05 | Re-order No. 303078 |
Principal Display Panel
MAJOR®
NDC 0904-7511-61
Unit Dose
Original Prescription Strength
Loratadine
Tablets
10 mg
Antihistamine
100 TABLETS (10 x 10)
10mg Carton Label (60162446 4fa1 4ee3 Ae20 19fadc2491ab 00)
* Please review the disclaimer below.
