LORATADINE- loratadine tablet 
SAFEWAY INC.

----------

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

adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor

OTHER INFORMATION

INACTIVE INGREDIENTS

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

QUESTIONS OR COMMENTS?

Call 1-888-SAFEWAY

PRINCIPAL DISPLAY PANEL

NDC 21130-526-13

Compare to Claritin®active ingredient

Original Prescription Strength

Non-Drowsy*

24-Hour

Allergy Relief

Loratadine Tablets, USP 10mg/ Antihistamine

INDOOR & OUTDOOR ALLERGIES

Relief of:

* When taken as directed. See Drug Facts Panel.

120 TABLETS

SAFEWAY®

DISTRIBUED BY SAFEWAY INC.

5082799/R0212

safewaylora
LORATADINE 
loratadine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-526
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
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Color white (White to Off-White) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code RX526
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:21130-526-69 1 in 1 CARTON
1 10 in 1 BLISTER PACK
2 NDC:21130-526-31 3 in 1 CARTON
2 10 in 1 BLISTER PACK
3 NDC:21130-526-43 1 in 1 CARTON
3 45 in 1 BOTTLE
4 NDC:21130-526-13 1 in 1 CARTON
4 120 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076134 06/06/2009
Labeler - SAFEWAY INC. (009137209)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 051565745 manufacture(21130-526)

Revised: 3/2014
Document Id: 11b3a031-0faa-4b14-bd2c-cd4b6f5c102c
Set id: 1092b8af-25f2-4c25-b3bc-5ffb14e96024
Version: 1
Effective Time: 20140325
 
SAFEWAY INC.