LORATADINE tablet, orally disintegrating

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by Valu Merchandisers 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

• place 1 tablet on tongue; tablet disintegrates, with or without water
  • 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

• Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet.
• TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
• store between 20° to 25° C (68° to 77° F). Protect from excessive moisture.
• keep in a dry place.
• use tablet immediately after opening individual blister.

INACTIVE INGREDIENTS

Aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate

QUESTIONS?

call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

‡COMPARE TO THE ACTIVE INGREDIENTS OF CLARITIN®REDITABS®

Best Choice®Brand

Original Prescription Strength

Non-Drowsy†

Allergy Relief

Loratadine Orally Disintegrating Tablets, 10 mg

24 Hour Allergy Relief

ANTIHISTAMINE

No Water Needed

Indoor & Outdoor Allergies

Melts in Your Mouth

For Adults & Children six years & older!

Relief of:

Sneezing; Runny Nose

Itchy, Watery Eyes; Itchy Throat or Nose

10 Orally Disintegrating Tablets

†When taken as directed.

See Drug Facts Panel.

DISTRIBUTED BY: VALU MERCHANDISERS, CO.

5079396/R0610

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63941-528
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
ASPARTAME (UNII: Z0H242BBR1)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)

Product Characteristics
Color	white (White to Off-White)	Score	no score
Shape	ROUND (Flat Faced Beveled Edge)	Size	10mm
Flavor	FRUIT	Imprint Code	RC17
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63941-528-69	10 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077153	08/31/2007

Labeler - Valu Merchandisers Company (868703513)

Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		051565745	manufacture(63941-528)