LORATADINE - loratadine tablet
Physicians Total Care, Inc.

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Drug Facts

Active Ingredient (in each tablet)

Loratadine, USP 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

How supplied

They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC	Strength	Quantity/Form	Color	Source Prod. Code
54868-5268-0	10 mg	30 Tablets in a Blister Pack	WHITE	45802-0650

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	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

Safety sealed: do not use if the imprinted bottle seal is open or torn.

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).

Inactive Ingredients

Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Questions or comments?

1 800 719-9260

This product is manufactured by:

Perrigo Company
515 Eastern Avenue Allegan
Michigan 49010

This Product was Relabeled with "Additional" barcode label By:

Physicians Total Care, Inc.
Tulsa, OK 74146

10 mg Label

NDC 54868-5268-0 Non-Drowsy*

image of 10 mg OTC package label

LORAtadineTablets, USP

10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour

Relief of:

• Sneezing

• Runny Nose

• Itchy, Watery

Eyes

• Itchy Throat

or Nose

* When taken as directed.

See Drug Facts Panel.

LORATADINE
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	54868-5268 (45802-0650)
Route of Administration	ORAL	DEA Schedule

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

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	6mm
Flavor		Imprint Code	L612
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	54868-5268-0	1 BLISTER PACK In 1 CARTON	contains a BLISTER PACK
1		30 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (54868-5268-0)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076301	04/18/2005

Labeler - Physicians Total Care, Inc. (194123980)

Establishment
Name	Address	ID/FEI	Operations
Physicians Total Care, Inc.		194123980	relabel

Revised: 05/2010Physicians Total Care, Inc.