Active Ingredient
(in each tablet)
Loratadine USP, 10 mg
Loratadine Tablet
FDA Label NDC 0378-8880
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mylan Pharmaceuticals Inc. for the product Loratadine (NDC 0378-8880). 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, 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.
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 of kidney disease | ask a doctor |
Other Information
- Tamper Evident: do not use if foil seal under cap is missing, open or broken.
- store between 20° to 25°C (68° to 77°F)
- protect from excessive moisture
Inactive Ingredients
Corn starch, lactose monohydrate and magnesium stearate.
Questions Or Comments?
call 1-877-446-3679 (1-877-4-INFO-RX)
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Made in India
Code No.: MH/DRUGS/25/NKD/89
Package Label.Principal Display Panel
PRODUCT PACKAGING
NDC 0378-8880-93
Original Prescription Strength
Non-Drowsy*
Loratadine
Tablets USP, 10 mg
Antihistamine
Indoor and Outdoor Allergies
24 Hour Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
*When taken as directed. See Drug Facts Panel.
RMX8880H1
30 Tablets
* Please review the disclaimer below.
