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Loratadine ODT by Major Pharmaceuticals

Dosage form: tablet, orally disintegrating
Ingredients: LORATADINE 10mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-5806

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
  • place 1 tablet on tongue; tablet disintegrates, with or without water
adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask 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

Keep the carton. It contains important information.

See end panel for expiration date.

Distributed By

MAJOR PHARMACEUTICALS

31778 Enterprise Drive

LIVONIA, MI 48150, USA

PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 0904-5806-15

Non-Drowsy*

Ages six years and older

Original Prescription Strength

Allergy

24 HOUR

Loratadine Orally Disintegrating Tablets, 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour Allergy Relief

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy
  • Watery Eyes
  • Itchy Throat or Nose

No water needed.

Melts in your mouth.

Fruit Flavors

10 Tablets/10 Days of Relief

10 Orally Disintegrating Tablets

*When taken as directed. See Drug Facts Panel.

Compare to the active ingredient of Claritin®RediTabs®

This product is not manufactured or distributed by Schering-Plough Healthcare Products, Inc.

CLARITIN®and REDITABS®are registered trademarks of Schering Corporation.

LORATADINE ODT 
loratadine tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5806
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
MANNITOL 
SODIUM STEARYL FUMARATE 
Product Characteristics
Colorwhite (White to Off-White) Scoreno score
ShapeROUND (flat faced beveled edge) Size10mm
FlavorSTRAWBERRY, TUTTI FRUTTI, MINTImprint CodeRC17
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5806-1510 TABLET, ORALLY DISINTEGRATING (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07715308/31/2007
Labeler - Major Pharmaceuticals (191427277)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIOperations
Ohm Laboratories Inc.051565745manufacture(0904-5806)

Revised: 08/2012
 
Major Pharmaceuticals

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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