Active Ingredient (In Each Tablet)
Loratadine, USP 10 mg
Loratadine Tablet
FDA Label NDC 63548-0753
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pld Acquisitions Llc Dba Av�ma Pharma Solutions for the product Loratadine (NDC 63548-0753). 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
- sneezing
- itchy, watery eyes
- 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.
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 printed bottle seal is open or torn
- store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature)
Inactive Ingredients
lactose monohydrate,magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9 AM-5 PM EST
Principal Display Panel
†Compare to the active ingredient in Claritin®
Loratadine tablets, USP
Antihistamine
10 mg
Non-drowsy*
Indoor & outdoor allergies
24-hour relief of
- sneezing
- itchy, watery eyes
- runny nose
- itchy throat or nose
100 Tablets
*When taken as directed. See Drug Facts panel
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Claritin®
Manufactured by:
Avema Pharm Solutions
10400 NW 29th Terrace, Miami, FL 33172
Package Label
Loratadine 10 mg Tablets
* Please review the disclaimer below.
