Loratadine Oral Solution, 5 mg/5 mL

Drug Facts

Active ingredient (in each 5 mL)

Loratadine 5 mg

Purpose

Antihistamine

Uses

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

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

Warnings

Do not useif you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

When using this productdo 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 right away.

Directions

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

Other information

safety sealed: do not use if imprinted safety seal is torn or missing
store between 2° and 25°C (36° and 77°F)

Inactive ingredients

artificial peach flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose

Questions?

Call 1-800-200-6313

DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

Carton LEADER®

NDC 37205-378-26

Compare to
Children's Claritin ®
active ingredient†

Original Prescription
Strength

NON-DROWSY*
Allergy
Relief
Loratadine Syrup
(Loratadine Oral Solution) 5 mg/5 mL

Antihistamine

24 Hour

Relief of: Sneezing, Runny Nose,
Itchy, Watery Eyes • Itchy Throat or Nose

Fruit Flavor

*When taken as directed.
See Drug Facts Panel.

Ages two years
and older

SATISFACTION
GUARANTEED

4 FL OZ (120 mL)

LORATADINE
loratadine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-378
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color		Score
Shape		Size
Flavor	PEACH	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37205-378-26	1 in 1 CARTON	08/20/2004	06/11/2025
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076805	08/20/2004	06/11/2025

Labeler - Cardinal Health (097537435)

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceutical Industries Ltd.		600072078	manufacture(37205-378)

Revised: 6/2025

Document Id: 3751ca31-ed5a-6c53-e063-6394a90adc2d

Set id: 6f881bd5-14c4-4077-ad03-1fae2d6ccb3b

Version: 4

Effective Time: 20250611

Cardinal Health