LORATADINE- loratadine tablet 
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

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:21130-526
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
Product Characteristics
Colorwhite (White to Off-White) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code RX526
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-526-691 in 1 CARTON
110 in 1 BLISTER PACK
2NDC:21130-526-313 in 1 CARTON
210 in 1 BLISTER PACK
3NDC:21130-526-431 in 1 CARTON
345 in 1 BOTTLE
4NDC:21130-526-131 in 1 CARTON
4120 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613406/06/2009
Labeler - SAFEWAY INC. (009137209)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745manufacture(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.