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

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

Inactive ingredients

butylated hydroxyanisole, glycerin, grape flavor, maltitol solution, masking agent, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sorbitol solution, sucralose powder

Questions?

Call 1-888-287-1915

DISTRIBUTED BY: Wal-Mart Stores, Inc.,
Bentonville, AR 72716

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC 49035-061-08

equate™

Compare
to Children's
Claritin®
Active
Ingredient*

Sugar Free

Ages 2 years and older

Children's
Allergy

Loratadine Oral Solution USP,
5mg/5mL (Antihistamine) Allergy

24 Hour Non-Drowsy**

Relieves:

Sneezing
Runny nose
Itchy, watery eyes
Itchy throat or nose

Original
Prescription
Strength

Dosage cup
enclosed

Indoor and
Outdoor Allergies

Dye Free Grape Flavor

4 FL OZ (120mL)

**When taken as directed
See Drug Facts Panel

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

CHILDRENS LORATADINE SUGAR FREE
loratadine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-061
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)
sorbitol (UNII: 506T60A25R)
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)
phosphoric acid (UNII: E4GA8884NN)
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	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49035-061-08	1 in 1 CARTON	03/17/2017
1		60 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	03/17/2017

Labeler - Wal-Mart Stores Inc (051957769)

Children's Loratadine Oral Solution Sugar Free