Active Ingredient
Drug Facts
Loratadine Tablets USP, 10 mg
Loratadine Tablet
FDA Label NDC 55154-4976
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 107, Llc for the product Loratadine (NDC 55154-4976). 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, 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
Non-Drowsy* 24 Hour
*When taken as directed. See Drug Facts Panel.
Indoor and Outdoor Allergies
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: · itching of the nose or throat · runny nose · itchy, watery eyes · sneezing
Warnings
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
This package is intended for institutional use only.
This unit-dose package is not child-resistant. If dispensed for outpatient use, a child-resistant container should be utilized.
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 |
FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Other Information
store between 20 and 25°C (68 and 77°F) · protect from excessive moisture.
Inactive Ingredients
corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch
Questions?
Questions? for Ranbaxy/Ohm Laboratories call 1-800-406-7984
The drug product contained in this package is from NDC#51660-526, Ohm Laboratories Inc.
Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217
americanhealthpackaging.com
An AmerisourceBergen Company
AMERICAN HEALTH PACKAGING is a trademark owned by its respective owner.
Repackaged by Cardinal Health
Zanesville, OH 43701
L4955647-10816
L4955647-20816
Principal Display Panel
Non-Drowsy* 24 Hour
Allergy Relief
Loratadine Tablets, USP 10 mg
Antihistamine
10 Tablets
* Please review the disclaimer below.
