Loratadine Tablet
FDA Label NDC 58602-831

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Loratadine (NDC 58602-831). 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, warnings, 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

Warnings

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 (1-800-222-1222) right away.

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


  • Tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken
  • store at 20° to 25°C (68° to 77°F)
  • protect from excessive moisture

Inactive Ingredients

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

Questions Or Comments?


call 1-855-274-4122

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648
 Made in India
Code: TS/DRUGS/22/2009

Package Label-Principal Display Panel - 10 Mg (45 Tablets Bottle)

NDC 58602-831-17
PH primary Health
Non-Drowsy*
Allergy Relief
Loratadine Tablets USP 10 mg
Antihistamine
Indoor & Outdoor Allergies

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

    • 24 Hour

     *When taken
    as directed
    See Drug
    Facts Panel.             45 Tablets

    Package Label-principal Display Panel (10 mg (45 Tablets Bottle))

    Package Label-principal Display Panel (10 mg (45 Tablets Bottle))

Package Label-Principal Display Panel - 10 Mg Container Carton (45 Tablets)

NDC 58602-831-17
PH primary Health
Non-Drowsy*
Allergy Relief
Loratadine Tablets USP 10 mg
Antihistamine
Indoor & Outdoor Allergies

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

    • 24 Hour

     *When taken
    as directed
    See Drug
    Facts Panel.             45 Tablets

    Fig2 (Loratadine Fig2)

    Fig2 (Loratadine Fig2)

* Please review the disclaimer below.