LORATADINE- loratadine tablet 
Cardinal Health

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Loratadine 10 mg

Active ingredient

In each tablet: Loratadine 10 mg

Purpose

Antihistamine

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose, sneezing, itchy, watery eyes and itching of the nose or throat.

Warnings

This package is intended for institutional use only.

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

If pregnant or breast-feeding, ask a health professional before use. 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

TAMPER EVIDENT FEATURE: Loratadine Tablets are safety sealed. Do not use if imprinted blister unit is open or torn.

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

Inactive ingredients

Lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Storage

Store at 15-30 C (59-86 F)

Protect from excessive moisture

Original Prescription Strength

*NON-DROWSY

24-Hour Allergy

Relief of Sneezing, Runny Nose, Itchy, Watery Eyes and Itchy Throat or Nose

*When taken as directed. See Drug Facts.

Manufactured and Distributed by:

Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622

Questions? call 1-800-452-0051 24 hours a day, 7 days a week

Repackaged by Cardinal Health

Zanesville, OH 43701

Principal Display Panel

Loratadine 10 mg

Antihistamine

10 Tablets

bag label
LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-9752(NDC:0067-6070)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize5mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-9752-010 in 1 BAG06/03/201111/30/2013
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02137506/03/201111/30/2013
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-9752)

Revised: 7/2018
 
Cardinal Health