Loratadine
FDA Label NDC 15127-979

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Select Brand for the product Loratadine (NDC 15127-979). 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 over1 tablet daily; not more than 1 tablet in 24 hours
    children under 6 years of ageask a doctor
    consumers with liver or kidney diseaseask 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

select brand®

NDC 15127-979-10

NON-DROWSY*

Original Prescription Strength

Allergy Relief Tablets

Loratadine Orally Disintegrating Tablets, 10 mg

Antihistamine

24 Hour Allergy Relief

Indoor & Outdoor Allergies

No Water Needed

Melts in Your Mouth

Relief of: Sneezing; Runny Nose;

Itchy, Watery Eyes; Itchy Throat or Nose

For Adults & Children six years & older!

10 Orally Disintegrating Tablets

٭Compare to the active ingredient of Claritin®RediTabs®

*When taken as directed. See Drug Facts Panel.

Distributed by: SELECT BRAND®DISTRIBUTORS

5079375/R0610

This Is The 10 Count Blister Carton Label For Select Brand Loratadine Odt. (Loraodt)

This Is The 10 Count Blister Carton Label For Select Brand Loratadine Odt. (Loraodt)

* Please review the disclaimer below.