CHILDRENS ALLERGY RELIEF- loratadine solution

Childrens by

Drug Labeling and Warnings

Childrens by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceutical Industries Ltd., Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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
• itchy, watery eyes
• sneezing
• 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° and 25°C (68° and 77°F)

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

SPL UNCLASSIFIED SECTION

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

CVS
Health™

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

Indoor & Outdoor
Allergies

NDC: 59779-093-08

Children's
Allergy

24
HOUR

LORATADINE
ORAL SOLUTION
USP, 5 mg/5 mL
(Antihistamine)
ALLERGY

Non-Drowsy*

• 24 hour relief of:
  Sneezing; Runny nose; Itchy,
  watery eyes; Itchy throat or nose
• Sugar free & Dye free
• Ages 2 yrs & older

WARNING: Contains sodium metabisulfite,
a sulfite that may cause allergic-type reactions.

*When taken as directed.
See Drug Facts Panel.

Grape Flavor
Dosing Cup Enclosed

4 FL OZ (120 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS   ALLERGY RELIEF
loratadine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-093
Route of Administration	ORAL

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
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
Color	YELLOW (colorless to slightly yellow)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-093-04	1 in 1 CARTON
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 59779-093-01	1 in 1 CARTON
2		240 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 59779-093-08	1 in 1 CARTON
3		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076805	02/27/2010

Labeler - CVS Pharmacy (062312574)

Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceutical Industries Ltd.		600072078	MANUFACTURE(59779-093)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(59779-093)