SUNMARK  CHILDRENS LORATADINE- loratadine solution 
McKesson

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Sunmark®
children's loratadine syrup

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:

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.

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

Inactive ingredients

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

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 49348-636-34

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

FRUIT 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 Type HUMAN OTC DRUG Item Code (Source) NDC:49348-636
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN) Loratadine 5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
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 YELLOW (colorless to slightly yellow) Score     
Shape Size
Flavor FRUIT Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49348-636-34 1 in 1 CARTON
1 120 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076805 08/20/2004
Labeler - McKesson (177667227)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Business Operations
Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(49348-636)

Revised: 11/2012
Document Id: 285e79a3-f79a-42e3-8462-ccbbe6f6ea65
Set id: ed94cba7-c2c4-4cbe-9021-f554a51d51f2
Version: 1
Effective Time: 20121112
 
McKesson