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 20° to 25° C (68° to 77° F)
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

call 1-800-406-7984

Distributed by C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995

QUALITY
CHOICE

NDC 63868-151-30

†Compare to
Active Ingredient in
CLARITIN®

Original Prescription Strength

Allergy Relief

Loratadine Tablets, USP
10 mg | Antihistamine

Indoor & Outdoor Allergies

Relief of:
Sneezing | Runny Nose
Itchy, Watery Eyes | Itchy Throat or Nose

24 Hour Allergy Relief | Non-Drowsy*

30 Tablets

*When taken as directed. See Drug Facts Panel.

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:63868-151-10	10 in 1 BLISTER PACK; Type 0: Not a Combination Product	08/19/2003
2	NDC:63868-151-30	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	08/19/2003
3	NDC:63868-151-01	100 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 - Chain Drug Marketing Association Inc. (011920774)

Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)

Name	Address	ID/FEI	Business Operations
Establishment
Ohm Laboratories Inc.		051565745	manufacture(63868-151)