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Loratadine by American Sales Company

Dosage form: tablet, orally disintegrating
Ingredients: LORATADINE 10mg
Labeler: American Sales Company
NDC Code: 41520-525

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 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

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

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 CodeRC17
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-525-6910 TABLET, ORALLY DISINTEGRATING (TABLET) 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 CodeRC17
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-527-6910 TABLET, ORALLY DISINTEGRATING (TABLET) 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/FEIOperations
Ohm Laboratories Inc.184769029manufacture(41520-525, 41520-527)

 
American Sales Company

← See all Loratadine brands

Medically reviewed on Jan 15, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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