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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55315-529
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:55315-529-3130 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07715308/31/2007
Labeler - Fred's Inc. (005866116)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745manufacture(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.