Loratadine Solution
FDA Label NDC 68001-449

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bluepoint Laboratories for the product Loratadine (NDC 68001-449). 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



Manufactured by:

Aurobindo Pharma Limited

Hyderabad-500 090,

India

For BluePoint Laboratories



Made in India


Code:TS/DRUGS/19/1993

Issued: 06/2020

Package Label-Principal Display Panel - 5 Mg/5 Ml (120 Ml Bottle)

NDC 68001-449-98



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



      4FL OZ (120 mL)



Package Label-Principal Display Panel - 5 Mg/5 Ml Carton (120 Ml)

NDC 68001-449-98

#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



      4 FL OZ (120 mL)







* Please review the disclaimer below.