Loratadine Tablet
FDA Label NDC 21130-526

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safeway Inc. for the product Loratadine (NDC 21130-526). 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 Or Comments?

Call 1-888-732-3929

Principal Display Panel

NDC 21130-526-38

Compare to Claritin®active ingredient†

24-HOURORIGINAL PRESCRIPTION STRENGTH

Allergy Relief

Loratadine Tablets, USP 10mg

Antihistamine

  • Non-Drowsy*
  • Relief of:

    Sneezing, runny Nose, itchy, watery eyes; itchy throat or nose

    • * When taken as directed. See Drug Facts Panel.

    365 TABLETS VALUE PACK

    SAFEWAY®

    DISTRIBUED BY SAFEWAY INC.

    5115097/0115

* Please review the disclaimer below.