FORMUCARE ALLERGY RELIEF - loratadine tablet
Access Business Group International LLC

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Access Business Group International LLC 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
sneezing
itchy, watery eyes
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

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

do not use if printed foil under cap is broken or missing
store at 20°-25°C (68°-77°F)

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-800-719-9260

Principal Display Panel

Non-Drowsy*

Allergy Relief

Loratadine Tablets, 10 mg

Antihistamine

Indoor & Outdoor Allergies

Original Prescription Strength

Relief of:

Sneezing; Runny Nose;

Itchy, Watery Eyes;

Itchy Throat or Nose

24 Hour

Actual Size

*When taken as directed. See Drug Facts Panel.

Allergy Relief Carton

FORMUCARE ALLERGY RELIEF
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	10056-612
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
No Inactive Ingredients Found

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	8mm
Flavor		Imprint Code	L612
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	10056-612-75	1 BOTTLE In 1 CARTON	contains a BOTTLE
1		90 TABLET In 1 BOTTLE	This package is contained within the CARTON (10056-612-75)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076301	01/27/2005

Labeler - Access Business Group International LLC (609682641)

Revised: 09/2009Access Business Group International LLC