Your browser does not support JavaScript! LORATADINE TABLET, ORALLY DISINTEGRATING [AMERICAN SALES COMPANY]
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RxNorm Names

LORATADINE tablet, orally disintegrating
[American Sales Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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 ingredient of Claritin®Reditabs®†

CAREONE®

Original Prescription Strength

Non-Drowsy*

24 hour

ALLERGY RELIEF

Loratadine Orally Disintegrating Tablets, 10 mg/Antihistamine

Indoor & Outdoor Allergies

NO WATER NEEDED · MELTS IN YOUR MOUTH

FOR ADULTS AND CHILDREN SIX YEARS AND 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: AMERICAN SALES COMPANY

5080282/R0211

This is the 10 count blister carton label for Careone Loratadine ODT, 10 mg.

Compare to the active ingredient of Claritin®RediTabs®†

CAREONE®

Original Prescription Strength

CHILDREN'S Non-Drowsy*

24 hour

ALLERGY RELIEF

Loratadine Orally Disintegrating Tablets, 10 mg/Antihistamine

Indoor & Outdoor Allergies

NO WATER NEEDED • MELTS IN YOUR MOUTH

FOR ADULTS AND CHILDREN SIX YEARS AND 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: AMERICAN SALES COMPANY

5080281/R0211

This is the bottle carton label for Careone 10 count Loratadine ODT, 10 mg (Claritin Kids).

LORATADINE 
loratadine tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-525
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
FlavorFRUITImprint Code RC17
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-525-6910 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07715308/31/2007
LORATADINE 
loratadine tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-527
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
FlavorFRUITImprint Code RC17
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-527-6910 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07715308/31/2007
Labeler - American Sales Company (809183973)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029manufacture(41520-525, 41520-527)

Revised: 01/2013
Document Id: 2362edeb-ac77-40c2-a066-757729e41e20
Set id: 178d708e-6091-4357-9dec-acfeb0cadfb3
Version: 1
Effective Time: 20130114
 
American Sales Company

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