LORATADINE ODT- loratadine tablet, orally disintegrating 
Safeway 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 OR COMMENTS?

Call 1-888-SAFEWAY

PRINCIPAL DISPLAY PANEL

NDC 21130-527-69

Compare to Claritin®RediTabs®active ingredient

Original Prescription Strength

Non-Drowsy*

24-Hour Allergy Relief

Loratadine Orally Disintegrating Tablets, 10 mg

Antihistamine

Indoor & Outdoor Allergies

Relief of:

For Adults and Children Six Years and Older

*When taken as directed.

See Drug Facts Panel.

10 ORALLY DISINTEGRATING TABLETS

SAFEWAY

DISTRIBUTED BY SAFEWAY INC.

5082800/R0212

This is the 10 count blister carton label for Safeway Loratadine ODT.

LORATADINE ODT 
loratadine tablet, orally disintegrating
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-527
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:21130-527-69 10 in 1 BLISTER PACK
2 NDC:21130-527-31 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 - Safeway Inc. (009137209)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 051565745 manufacture(21130-527)

Revised: 9/2012
Document Id: d5ec9af0-b2a0-47cd-a418-cfc00df2afd8
Set id: 244e041f-20e2-4e38-ac6b-bf96f8724d5e
Version: 1
Effective Time: 20120925
 
Safeway Inc.