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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-513
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
MANNITOL 
SODIUM STEARYL FUMARATE 
Product Characteristics
Colorwhite (White to Off-White) Scoreno score
ShapeROUND (Flat Faced Beveled Edge) Size10mm
FlavorFRUITImprint Code RC17
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-513-2424 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07715308/31/2007
Labeler - American Sales Company (809183973)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029manufacture(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