Loratadine Oral Solution USP 5 mg/5 mL

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LORATADINE- loratadine oral solution 
Preferred Pharmaceuticals Inc.

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Loratadine Oral Solution USP 5 mg/5 mL

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

Relabeled By: Preferred Pharmaceuticals Inc.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (120 mL Bottle)

NDC: 68788-8335-1
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)

Loratadine Oral Solution 5mg/5mL
LORATADINE 
loratadine oral solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68788-8335(NDC: 68001-449)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
GRAPE (UNII: 6X543N684K)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTITOL (UNII: D65DG142WK)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Coloryellow (colorless to light yellow) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68788-8335-11 in 1 CARTON01/23/202307/23/2025
1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20893101/23/202307/23/2025
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8335)

Revised: 7/2025