Loratadine Capsule, Liquid Filled
FDA Label NDC 58602-818

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 58602-818). 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 drug facts, 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

Drug Facts

Active ingredient

 (in each capsule)

Loratadine USP 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  •  itchy, watery eyes
  • 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 capsule daily; not more than 1 capsule in 24 hours
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

Other Information

  • do not use if the individual blister unit is open or torn
  • store between 20° to 25°C (68° to 77°F)
  • protect from freezing
  • FDA approved dissolution test specifications differ from USP

Inactive Ingredients

Gelatin, glycerin, glyceryl monocaprylocaprate, hypromellose, isopropyl alcohol, Neelicert FD&C Blue No.1, polysorbate 80, povidone, propylene glycol, purified water, sorbitol sorbitan solution and titanium dioxide.

Questions Or Comments?

 call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/22/2009

Package Label-Principal Display Panel - 10 Mg (10 Capsule Blister Carton)

AUROHEALTH

NDC 58602-818-83

Compare to the active ingredient

in Claritin® Liqui-Gels®†

Non-Drowsy*

Loratadine Capsules USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

Relief of:

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

    • 24 HOUR

    10 Liquid-Filled Capsules

    *When taken as directed.

    See Drug Facts Panel.

    Package Label-principal Display Panel (10 mg (10 Capsule Blister Carton))

    Package Label-principal Display Panel (10 mg (10 Capsule Blister Carton))


* Please review the disclaimer below.