LORATADINE- loratadine tablet, orally disintegrating 
American Sales Company

----------

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:

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

OTHER INFORMATION

INACTIVE INGREDIENTS

Aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient of Alavert®†

CAREONE®

Original Prescription Strength

Non-Drowsy*

24 hour

ALLERGY RELIEF

Loratadine Orally Disintegrating Tablets, 10 mg/Antihistamine

Indoor & Outdoor Allergies

NO WATER NEEDED · MELTS IN YOUR MOUTH

FOR ADULTS AND CHILDREN SIX YEARS AND OLDER!

Relief of:

24 Orally Disintegrating Tablets

*When taken as directed.

See Drug Facts Panel.

DISTRIBUTED BY: AMERICAL SALES COMPANY

5080283/R0211

This is the 24 count blister carton label for Careone Loratadine ODT, 10 mg.
LORATADINE 
loratadine tablet, orally disintegrating
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-513
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME (UNII: Z0H242BBR1)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
Product Characteristics
Color white (White to Off-White) Score no score
Shape ROUND (Flat Faced Beveled Edge) Size 10mm
Flavor FRUIT Imprint Code RC17
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-513-24 24 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077153 08/31/2007
Labeler - American Sales Company (809183973)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 184769029 manufacture(41520-513)

Revised: 1/2013
Document Id: b9692ba4-8ebc-40db-a9e0-87a4369f5fc1
Set id: 04a54364-7f13-4b23-8445-9cbc57733e18
Version: 1
Effective Time: 20130114
 
American Sales Company