LORATADINE ANTIHISTAMINE- loratadine tablet 
Padagis Israel Pharmaceuticals Ltd

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Perrigo Loratadine Tablets, 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
•
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

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

•
do not use if printed foil under cap is broken or missing
•
store between 20° to 25°C (68° to 77°F)

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Claritin® active ingredient

Original Prescription Strength

Non-Drowsy*

Loratadine Tablets, 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

*When taken as directed. See Drug Facts Panel.

actual size

30 TABLETS

Padagis™

loratadine-image
LORATADINE  ANTIHISTAMINE
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45802-650
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)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize8mm
FlavorImprint Code L612
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45802-650-651 in 1 CARTON10/15/2008
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:45802-650-781 in 1 CARTON10/07/2009
2100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:45802-650-871 in 1 CARTON10/28/2008
3300 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:45802-650-751 in 1 CARTON09/15/2023
490 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07630110/15/2008
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)

Revised: 10/2023
Document Id: 4f7517ac-f9f3-40cd-b0c9-0b5ae2463701
Set id: c72d8a30-520e-4d25-8f02-0c891e070a1a
Version: 6
Effective Time: 20231004
 
Padagis Israel Pharmaceuticals Ltd