HEALTHMART CHILDRENS LORATADINE- loratadine solution

HealthMart by

Drug Labeling and Warnings

HealthMart by is a Otc medication manufactured, distributed, or labeled by McKesson, Taro Pharmaceuticals U.S.A., Inc., 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

• safety sealed: do not use if imprinted safety seal is torn or missing
• 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 McKesson
One Post Street
San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 120 ml Bottle Carton

NDC: 62011-0181-1

HealthMart®
PHARMACY

compare to
Children's Claritin®
active ingredient*

children's
loratadine
syrup
(loratadine oral solution)
5 mg/5 mL antihistamine

indoor & outdoor allergies
original prescription strength

24 hour non-drowsy† relief of:
sneezing; runny nose;
itchy, watery eyes; itchy throat or nose

2 Yrs. & older

sugar free grape flavor

dosing cup included

alcohol free

4 FL OZ
(120 ml)

†when taken as directed.
see drug facts panel.

INGREDIENTS AND APPEARANCE

HEALTHMART   CHILDRENS LORATADINE
loratadine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62011-0181
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: 62011-0181-1	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	02/27/2010

Labeler - McKesson (177667227)

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

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(62011-0181)