Loratadine
FDA Label NDC 53329-651

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Inc. for the product Loratadine (NDC 53329-651). 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

Active Ingredient (In Each Tablet)

Loratadine USP, 10 mg

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 or kidney disease ask a doctor

Other Information

  • store between 20 and 25° C (68 and 77° F)
  • protect from excessive moisture
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Inactive Ingredients

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions?

Call 1-800-MEDLINE (633-5463), Monday - Friday, 9AM - 5PM CST

Principal Display Panel

MEDLINE

NDC 53329-651-33

†Compare to the active ingredient in Claritin®

NON-DROWSY*

LORATADINE TABLETS, USP 10 mg

ANTIHISTAMINE

ALLERGY RELIEF

Indoor & Outdoor Allergies

24 HOUR RELIEF of:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

10 mg

30 Tablets

(When taken as directed. See Drug Facts Panel.)

Distributed by: Medline, Industries, Inc.

5099016/1012

30's Bottle Label (Loratadine)

30's Bottle Label (Loratadine)

* Please review the disclaimer below.