LORATADINE ANTIHISTAMINE- loratadine tablet 
Aphena Pharma Solutions - Tennessee, LLC

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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:

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

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-800-719-9260

Repackaging Information

Please reference the HOW SUPPLIED section listed above for a description of individual drug products listed below. This drug product has been received by Aphena Pharma Solutions - Tennessee, LLC in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

10mg
NDC 43353-259-60, Bottles of 90 Tablets
NDC 43353-259-18, Bottles of 3000 Tablets
NDC 43353-259-09, Bottles of 9000 Tablets

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TN
Cookeville, TN 38506

20240409AMH

PRINCIPAL DISPLAY PANEL - 10 mg

NDC 43353-259 - Loratadine 10 mg Tablets
Bottle Label 10 mg

LORATADINE  ANTIHISTAMINE
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43353-259(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:43353-259-6090 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2016
2NDC:43353-259-183000 in 1 BOTTLE; Type 0: Not a Combination Product10/17/2022
3NDC:43353-259-099000 in 1 BOTTLE; Type 0: Not a Combination Product09/08/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07630110/15/2008
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Tennessee, LLC128385585repack(43353-259)

Revised: 4/2024
Document Id: 15aaaeb4-fda5-f5e2-e063-6394a90a47ee
Set id: a2c92766-df4e-4414-9c42-e18bcf9db6b4
Version: 5
Effective Time: 20240409
 
Aphena Pharma Solutions - Tennessee, LLC