SUNMARK  CHILDRENS LORATADINE- loratadine solution 
McKesson

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sunmark®
Children's 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:

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

Distributed by McKesson
One Post Street, San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

sunmark®

COMPARE TO
CHILDREN'S CLARITIN®
ACTIVE INGREDIENT*

NDC 49348-333-34

24 HOUR
ALLERGY RELIEF

children's
loratadine
syrup

(Loratadine Oral Solution)
5 mg/5 mL Antihistamine

Relief of
sneezing, runny nose
itchy, watery eyes
itchy throat or nose

Dye Free
Non-drowsy†
Ages two years & older

SUGAR FREE
GRAPE FLAVOR

4 FL OZ (120 mL)

†When taken as directed. See Drug Facts Panel.

Principal Display Panel - 120 mL Bottle Carton
SUNMARK   CHILDRENS LORATADINE
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-333
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN) Loratadine5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
glycerin (UNII: PDC6A3C0OX)  
sorbitol (UNII: 506T60A25R)  
phosphoric acid (UNII: E4GA8884NN)  
polyethylene glycols (UNII: 3WJQ0SDW1A)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sodium metabisulfite (UNII: 4VON5FNS3C)  
sodium phosphate, monobasic, dihydrate (UNII: 5QWK665956)  
Product Characteristics
ColorYELLOW (colorless to slightly yellow) Score    
ShapeSize
FlavorGRAPE (sugar free) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-333-341 in 1 CARTON
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680502/27/2010
Labeler - McKesson (177667227)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Revised: 8/2015
Document Id: 42c6a214-9cc6-4939-806c-42d8d33cfdcc
Set id: 0cd1a8be-4184-4534-99f9-0fcc0dcc5224
Version: 2
Effective Time: 20150807
 
McKesson