Loratadine Tablet
FDA Label NDC 80513-711

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Llc for the product Loratadine (NDC 80513-711). 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, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy 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 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

Otc - Do Not Use

Do not useif you have ever had an allergic reaction to this product or any of its ingredients.

Otc - Ask Doctor

 Ask a doctor before use ifyou haveliver or kidney disease. Your doctor should determine if you need a different dose.

Otc - When Using

When using this productdo not take more than directed. Taking more than directed may cause drowsiness.

Otc - Stop Use

Stop use and ask doctor ifan allergic reaction to this product occurs. Seek medical help right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

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

  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture

Inactive Ingredients​

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate

Questions?

call 1-800-630-8895

Principal Display Panel

NDC 80513-711-03

Compare to the Active Ingredient in Claritin ®*

Loratadine 10 mg

Allergy Relief

Non-Drowsy**

Antihistamine

24 Hour Relief of:

  • Sneezing, runny nose
  • Itchy, watery eyes
  • Itchy throat or nose

    • Original Prescription Strength

    **When Taken as Directed. See Drug Facts Panel.

    300 Tablets

    DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

    *This product is not manufactured or distributed by the owner of the registered trademark Claritin ®

    Distributed by:

    ADVANCED RX LLC,

    1942 NE 163rd St

    North Miami Beach,

    FL 33162 U.S.A.

    Loratadine-10mg-blisterlabel-jpg (Label)

    Loratadine-10mg-blisterlabel-jpg (Label)

* Please review the disclaimer below.