Topcare Allergy Relief

Pronunciation

Generic Name: loratadine
Dosage Form: tablet, orally disintegrating

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Topco Allergy Relief Drug Facts

Active ingredient (in each tablet)

Loratadine 10 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.

Directions

place 1 tablet on tongue; tablet disintegrates, with or without water

adults and children 6 years and over	1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

Phenylketonurics: contains Phenylalanine 0.9 mg per tablet
do not use if blister unit is broken or torn
store between 20° to 25°C (68° to 77°F)
use tablet immediately after opening individual blister

Inactive ingredients

anhydrous citric acid, artificial cherry flavor, aspartame, colloidal silicon dioxide, crospovidone, lactose monohydrate, mannitol, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium stearate

Questions or comments?

1-888-423-0139

Principal Display Panel

Melt-in-your-mouth tablets

24 hour

Non-Drowsy*

Allergy Relief

Loratadine Orally Disintegrating Tablets, 10 mg

Antihistamine

Melteez™ Tablets

No water needed

For 24 hour Relief of:

Sneezing, Itchy Throat or Nose, Itchy, Watery Eyes, Runny Nose

Actual Size

Compare to Claritin® RediTabs® active ingredient

*When taken as directed. See Drug Facts Panel.

Allergy Relief Carton

Topcare Allergy Relief
loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-311
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (LORATADINE)	LORATADINE	10 mg

Product Characteristics
Color	WHITE (to off white)	Score	no score
Shape	ROUND	Size	7mm
Flavor	CHERRY	Imprint Code	none
Contains

Packaging
#	Item Code	Package Description
1	NDC:36800-311-52	1 BLISTER PACK (BLISTER PACK) in 1 CARTON
1		10 TABLET, ORALLY DISINTEGRATING (TABLET) in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075990	02/03/2004

Labeler - Topco Associates LLC (006935977)

Revised: 07/2009

Topco Associates LLC

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