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:

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

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

store between 20° to 25° C (68° to 77° F)
protect from excessive moisture
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

INACTIVE INGREDIENTS

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

QUESTIONS OR COMMENTS?

Call 1-888-732-3929

PRINCIPAL DISPLAY PANEL

NDC 21130-526-38

Compare to Claritin®active ingredient

24-HOURORIGINAL PRESCRIPTION STRENGTH

Allergy Relief

Loratadine Tablets, USP 10mg

Antihistamine

Non-Drowsy*
Relief of:

Sneezing, runny Nose, itchy, watery eyes; itchy throat or nose

* When taken as directed. See Drug Facts Panel.

365 TABLETS VALUE PACK

SAFEWAY®

DISTRIBUED BY SAFEWAY INC.

5115097/0115

safewaylora
LORATADINE 
loratadine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-526
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
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; Type 0: Not a Combination Product
2 NDC:21130-526-31 3 in 1 CARTON
2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3 NDC:21130-526-43 1 in 1 CARTON
3 45 in 1 BOTTLE; Type 0: Not a Combination Product
4 NDC:21130-526-13 1 in 1 CARTON
4 120 in 1 BOTTLE; Type 0: Not a Combination Product
5 NDC:21130-526-38 1 in 1 CARTON
5 365 in 1 BOTTLE; Type 0: Not a Combination Product
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: 3/2015
Document Id: 75d455cf-14b2-4000-b125-14da7676883d
Set id: 1092b8af-25f2-4c25-b3bc-5ffb14e96024
Version: 2
Effective Time: 20150311
 
SAFEWAY INC.