Drug Facts

Active ingredient (in each tablet)

Loratadine, USP 10 mg

Purpose

Antihistamine

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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).

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

store between 68° to 77° F (20° to 25° C)
protect from excessive moisture
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811

NDC 56062-526-69

INDOOR & OUTDOOR ALLERGIES
24-HOUR

allergyrelief

LORATADINE TABLETS, USP 10 mg

ANTIHISTAMINE

Non-drowsy*
Relief of:
• Sneezing • Runny nose
• Itchy, watery eyes
• Itchy throat or nose

10 TABLETS

*When taken as directed. See Drug Facts Panel.

ACTUAL SIZE

†Compare to the active
ingredient of Claritin®

LORATADINE
loratadine tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:56062-526-69	10 in 1 BLISTER PACK; Type 0: Not a Combination Product	08/19/2003
2	NDC:56062-526-31	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	08/19/2003
3	NDC:56062-526-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	08/19/2003

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076134	08/19/2003

Labeler - Publix Super Markets Inc (006922009)

Registrant - Sun Pharmaceutical Industries Inc. (146974886)

Name	Address	ID/FEI	Business Operations
Establishment
Ohm Laboratories Inc.		051565745	manufacture(56062-526)