Loratadine
FDA Label NDC 59564-251

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Innovative Manufacturing And Distribution Services, Inc. for the product Loratadine (NDC 59564-251). 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 breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Loratadine 10mg

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

  • side effects occur.

    • You may report side effects to FDA at 1-800-FDA-1088.

If Pregnant Or Breastfeeding

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 imprinted bottle seal is open or torn
  • Store at 15° - 30° C (59° - 86° F).

Inactive Ingredients

Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Package/Label Principal Display Panel

Loratadine 30 Tablet Label (603b96bf Ab3f 4ac2 966b 8060f1cfe745 01)

Loratadine 30 Tablet Label (603b96bf Ab3f 4ac2 966b 8060f1cfe745 01)

IMDS INC.

Loratadine

(Compare to Claritin®)

30 TABLETS

10 mg

Relief of: Sneezing, Runny Nose,

Itchy Watery Eyes, Itchy Throat or Nose

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