WESTERN FAMILY  CHILDRENS ALLERGY RELIEF- loratadine solution 
Western Family Foods Inc

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Western Family®
Children's Allergy Relief

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:

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

adults and children 6 years and over2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
children 2 to under 6 years of age1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
children under 2 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

Inactive ingredients

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

Questions?

Call 1-866-923-4914

Proudly Distributed by
Western Family Foods, Inc.
P.O. Box 4057, Portland, OR 97208 U.S.A.

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

WESTERN FAMILY®

INDOOR & OUTDOOR ALLERGIES

Children's
Allergy
RELIEF

24 HOUR
Non-Drowsy

LORATADINE
ORAL SOLUTION 5 mg / 5 mL
Antihistamine

2 years
and older

sugar free
Grape
flavored
syrup

24 HOUR RELIEF OF:
✓SNEEZING
✓RUNNY NOSE
✓ITCHY, WATERY EYES
✓ITCHY THROAT OR NOSE

When taken as directed. See Drug Facts Panel.

4 FL OZ (120 mL)

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S CLARITIN®*

Principal Display Panel - 120 mL Bottle Carton
WESTERN FAMILY   CHILDRENS ALLERGY RELIEF
loratadine solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55312-092
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loratadine (Loratadine) Loratadine5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
glycerin 
sorbitol 
phosphoric acid 
polyethylene glycols 
propylene glycol 
water 
sodium benzoate 
sodium metabisulfite 
sodium phosphate, monobasic, dihydrate 
Product Characteristics
ColorYELLOW (colorless to slightly yellow) Score    
ShapeSize
FlavorGRAPE (sugar free) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-092-081 in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680502/27/2010
Labeler - Western Family Foods Inc (192166072)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(55312-092)

Revised: 3/2014
Document Id: 56dbc128-2638-4e66-b01d-10394e177073
Set id: 2ac0d97a-35a9-4656-a614-1c8c06a89650
Version: 2
Effective Time: 20140327
 
Western Family Foods Inc