Claritin Tablet
FDA Label NDC 70264-030

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by R J General Corporation for the product Claritin (NDC 70264-030). 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 claritin ®, use, warnings, directions, other information, inactive ingredients, questions and comments?, principal display panel - 25 tablet pouch carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Claritin ®

Active ingredients (in each tablet)

Purpose

Loratadine 10 mg

Antihistamine

Use

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 don not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding, ask 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
 consumer with liver or kidney disease 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 o to 25 o C (68 o to 77 o F)
  • Protect from excessive moisture

Inactive Ingredients

Coen starch, lactose monohydrate, magnesium stearate

Questions And Comments?

1-800-CLARITIN(1-800-252-7484) or www.claritin.com

Dist. by: Bayer HealthCare LLC

Whippany, NJ 07981

Product of Ireland

Do not use if pouch is torn or broken.

Repackaged and distributed by:

RJ General

2024 Northwest Drive

Cincinnati OH 45231

Principal Display Panel - 25 Tablet Pouch Carton

Non-Drowsy*

Claritin ®

loratadine tablets 10 mg/ antihistamine

Indoor & Outdoor Allergies

Relief of:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the throat or nose 

    • Image Description (Claritin Carton Label)

    Image Description (Claritin Carton Label)

* Please review the disclaimer below.