LORATADINE- loratadine oral solution

Drug Labeling and Warnings

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine oral solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-8335(NDC:68001-449)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow (colorless to light yellow)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-8335-1	1 in 1 CARTON	01/23/2023
1		120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208931	01/23/2023

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals Inc.		791119022	RELABEL(68788-8335)