Active Ingredient (In Each Tablet)
Loratadine 10 mg
Claritin Tablet
FDA Label NDC 67751-153
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Navajo Manufacturing Company for the product Claritin (NDC 67751-153). 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, 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 right away.
Directions
adults and Children 12 years and older | 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 diseases | Ask a doctor |
Other Information
• safety sealed: do not use if the individual blister unit imprinted with Claritin® is open or torn
• store between 20° to 25° C (68° to 77° F)
• protect from excessive moisture
Inactive Ingredients
corn starch, lactose monohydrate, magnesium stearate
Questions Or Comments?
1-800-CLARITIN (1-800-252-7484) or www.claritin.com
Package Labeling:
Claritin (Claritin)
* Please review the disclaimer below.
