Loratadine
FDA Label NDC 63941-528

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Valu Merchandisers Company for the product Loratadine (NDC 63941-528). 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 (1-800-222-1222).

Directions

  • place 1 tablet on tongue; tablet disintegrates, with or without water
    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

  • Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet.
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25° C (68° to 77° F). Protect from excessive moisture.
  • keep in a dry place.
  • use tablet immediately after opening individual blister.

Inactive Ingredients

Aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate

Questions?

call 1-800-406-7984

Principal Display Panel

‡COMPARE TO THE ACTIVE INGREDIENTS OF CLARITIN®REDITABS®

Best Choice®Brand

Original Prescription Strength

Non-Drowsy†

Allergy Relief

Loratadine Orally Disintegrating Tablets, 10 mg

24 Hour Allergy Relief

ANTIHISTAMINE

No Water Needed

Indoor & Outdoor Allergies

Melts in Your Mouth

For Adults & Children six years & older!

Relief of:

Sneezing; Runny Nose

Itchy, Watery Eyes; Itchy Throat or Nose

10 Orally Disintegrating Tablets

†When taken as directed.

See Drug Facts Panel.

DISTRIBUTED BY: VALU MERCHANDISERS, CO.

5079396/R0610

10's Blister Carton Label (Loraodt)

10's Blister Carton Label (Loraodt)

* Please review the disclaimer below.