LORATADINE OD- loratadine tablet, orally disintegrating 
Fred's 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:

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

fred's

Non-Drowsy*

Allergy Relief

Loratadine Orally Disintegrating Tablets, 10 mg

Antihistamine

No Water Needed, Melts In Your Mouth!

INDOOR & OUTDOOR ALLERGIES

24 hour relief of:

Compare To Active Ingredient of Claritin® RediTabs®†

30 Orally Disintegrating Tablets

*When taken as directed. See Drug Facts Panel.

DISTRIBUTED BY: fred's, Inc.

5091232/R1111

This is the 30 count blister carton label for Fred's Loratadine ODT, 10 mg.
LORATADINE OD 
loratadine tablet, orally disintegrating
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-529
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:55315-529-31 30 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 - Fred's Inc. (005866116)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 051565745 manufacture(55315-529)

Revised: 1/2013
Document Id: cf0be8c3-50d2-4b7f-8120-33754890e2b2
Set id: 5f246f7a-a221-49d1-94cb-526e0685f48c
Version: 1
Effective Time: 20130108
 
Fred's Inc.