Loratadine Solution
FDA Label NDC 58602-423

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 58602-423). 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 5 mL teaspoonful)
Loratadine USP 5 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


  • use only with enclosed dosing cup

    • adults and children 6 years and over
    		2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours 
    children 2 to under 6 years of age
    		1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
    children under 2 years of age
    		ask a doctor
    consumers with liver or kidney disease
    		ask a doctor

Other Information

  • each teaspoonful contains: sodium 6 mg
  • do not use if carton is opened, or if cap safety seal is broken or missing.
  • store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

artificial flavors, ascorbic acid, glycerin, maltitol, monobasic sodium phosphate monohydrate, phosphoric acid, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose.

Questions Or Comments?

Call 1-855-274-4122

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India

 Code:TS/DRUGS/19/1993





Package Label-Principal Display Panel - 5 Mg/5 Ml  (60 Ml Bottle)

NDC 58602-423-11

Ages
2 years
and older

Loratadine
Oral Solution USP
5 mg/5 mL

Antihistamine
 Non-Drowsy*

24 Hour Relief of:

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

    • Do not use if carton is opened,
    or if cap safety seal is broken
     or missing.

    • Dye-Free
    • Sugar-Free
    • Alcohol Free 

      • Indoor & Outdoor Allergies 


      Contains sodium metabisulfite,
      a sulfite that may cause
      allergic-type reactions.



      * When taken as directed. See Drug Facts Panel.

      Grape       Flavor

      2 FL OZ (60 mL)

      Package Label-principal Display Panel (5 mg/5 mL (60 mL Bottle))

      Package Label-principal Display Panel (5 mg/5 mL (60 mL Bottle))


Package Label-Principal Display Panel - 5 Mg/5 Ml Carton (60 Ml)

NDC 58602-423-11

#Compare to the
 active ingredient in
children’s Claritin®


Ages  

2years
and older

Loratadine
Oral Solution USP
5 mg/5 mL

Antihistamine

Non-Drowsy*

24 Hour Relief of:


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

    •    


    Indoor & Outdoor Allergies

    Dosing Cup Included


    • Dye-Free

      • Contains sodium
      metabisulfite, a sulfite
      that may cause
      allergic-type reactions.


       * When taken as directed.

      See Drug Facts Panel.

      Grape

       Flavor

       2 FL OZ (60 mL)


      Package Label-principal Display Panel (5 mg/5 mL Carton (60 mL))

      Package Label-principal Display Panel (5 mg/5 mL Carton (60 mL))




* Please review the disclaimer below.