Loratadine

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Loratadine 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 right away. (1-800-222-1222)

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 5 mg
do not use if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing.
store between 20° and 25°C (68° and 77°F)
see bottom panel for lot number and expiration date

Inactive ingredients

bubble gum flavor, butylated hydroxyanisole, glycerin, maltitol solution, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sucralose powder

Questions?

Call 1-866-923-4914

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 240 mL Bottle Carton

Walgreens

Compare to the active ingredient in Children's Claritin®††

NDC 0363-0771-01

Children's Allergy Relief

LORATADINE
ORAL SOLUTION
USP 5 mg/5 mL
(ANTIHISTAMINE) ALLERGY

Dye Free Sugar Free

24-Hour Relief Non-Drowsy*

24-hour relief of runny nose; sneezing; itchy throat or nose & itchy, watery eyes
Indoor & outdoor allergies

AGES 2 YEARS & OLDER

8 FL OZ (240 mL)

now Bubble Gum flavor

PRINCIPAL DISPLAY PANEL - 240 mL Bottle Carton

LORATADINE
loratadine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0771
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
butylated hydroxyanisole (UNII: REK4960K2U)
glycerin (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
sorbitol (UNII: 506T60A25R)
phosphoric acid (UNII: E4GA8884NN)
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sodium phosphate, monobasic, dihydrate (UNII: 5QWK665956)

Product Characteristics
Color	YELLOW (colorless to slightly yellow)	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-0771-01	1 in 1 CARTON	04/19/2023
1		240 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	ANDA201865	04/19/2023

Labeler - WALGREEN COMPANY (008965063)

Revised: 4/2023

Document Id: 459ad627-7379-4772-88af-1f4cdc854be8

Set id: 3881afaf-8d0d-4154-85a8-79a3c7806b49

Version: 2

Effective Time: 20230424

WALGREEN COMPANY