Loratadine Tablet
FDA Label NDC 59779-528

14 label sections · Submitted to the FDA by Cvs Pharmacy · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Loratadine (NDC 59779-528). 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

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° to 25° C (68° to 77° F)
  • protect from excessive moisture
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive Ingredients

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions?

Call 1-800-406-7984

Principal Display Panel - 10 Mg Tablet Bottle Carton

CVSHealth™

Compare to the active
ingredient in Claritin®†

Indoor & Outdoor Allergies

Original Prescription Strength

Non-Drowsy*

Allergy Relief

LORATADINE TABLETS, USP 10 mg
Antihistamine

24 Hour Relief of:

  • 1.Sneezing
  • 2.Runny nose
  • 3.Itchy, watery eyes
  • 4.Itchy throat or nose

    • 24
    HOUR

    Actual Bottle Size on Side Panel
    Package Contains One Bottle

    45 TABLETS

    Actual Size

    *When taken as directed.
    See Drug Facts Panel.

    Principal Display Panel (10 mg Tablet Bottle Carton)

    Principal Display Panel (10 mg Tablet Bottle Carton)

* Please review the disclaimer below.