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

LORATADINE OD
loratadine tablet, orally disintegrating
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-529
Route of Administration ORAL
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.