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Loratadine by Cardinal Health

Medically reviewed on June 4, 2018

Dosage form: tablet
Ingredients: LORATADINE 10mg
Labeler: Cardinal Health
NDC Code: 55154-6676

Loratadine Tablet 10 mg

Drug Facts

Active ingredient (in each tablet)

Loratadine 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
sneezing
itchy, watery eyes
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.

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
1.
safety sealed: do not use if induction seal, with "Lift N Peel" tab, under cap is broken or missing
2.
store between 2° and 30°C (36° and 86°F)
3.
protect from exceesive moisture

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose

Manufactured by:

Manufactured for:

Apotex Inc.

Apotex Corp.

Toronto, Ontario

Weston, Florida

Canada M9L 1T9

33326

Revised: March 2005


Cardinal Health

Zanesville, OH 43701

IH50553140115

Principal Display Panel

Loratadine Tablet, USP

10 mg

Principal Display Panel

Loratadine Tablets, USP

10 mg

100 Tablets

Principal Display Panel

Loratadine Tablets, USP

10 mg

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-6676(NDC:60505-0147)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize8mm
FlavorImprint CodeLOR;10;APO
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-6676-4100 BLISTER PACK in 1 CARTON
1NDC:55154-6676-71 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07647101/24/2005
Labeler - Cardinal Health (188557102)
Registrant - Apotex Inc. (209429182)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK(55154-6676)

 
Cardinal Health

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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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