Loratadine by Walgreen Company / Ranbaxy Pharmaceuticals Inc. / Ohm Laboratories Inc. LORATADINE tablet

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, Ranbaxy Pharmaceuticals Inc., Ohm Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

INACTIVE INGREDIENTS

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

QUESTIONS?

Call 1-800-406-7984

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton

NON-DROWSY*
Wal-itin®
24 Hour Allergy
Loratadine Tablets, USP 10 mg
Antihistamine

• Relief of runny nose,
  sneezing, itchy throat or nose &
  itchy, watery eyes

5 TABLETS

Actual Size

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDED‡

NDC: 0363-0522-56

INDOOR &
OUTDOOR
ALLERGIES

24
HOUR

Compare to Claritin®
active ingredient‡‡

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0522
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: 0363-0522-71	1 in 1 CARTON	12/05/2013
1		70 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0363-0522-55	1 in 1 CARTON	12/05/2013
2		150 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 0363-0522-78	1 in 1 CARTON	12/05/2013
3		300 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 0363-0522-21	2 in 1 CARTON	12/05/2013
4		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 0363-0522-69	1 in 1 CARTON	12/05/2013
5		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC: 0363-0522-30	1 in 1 CARTON	12/05/2013
6		30 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 0363-0522-43	1 in 1 CARTON	12/05/2013
7		45 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 0363-0522-56	1 in 1 CARTON	12/05/2013
8		5 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076134	12/05/2013

Labeler - Walgreen Company (008965063)

Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		051565745	manufacture(0363-0522)