LORATADINE ALLERGY RELIEF- loratadine tablet 
Marlex Pharmaceuticals, Inc.

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Loratadine Allergy Relief

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:

Warnings

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

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

When using this productdo not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor ifan 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 over1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other Information

Inactive ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Manufactured for/ Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 10/22 SP

PRINCIPAL DISPLAY PANEL

Loratadine 10mg Tablets

NDC 10135-0763-30

30 Tablets

label1

Loratadine 10mg Tablets

NDC 10135-0763-90

90 Tablets

763-90

Loratadine 10mg Tablets

NDC 10135-0763-03

300 Tablets

label3

LORATADINE ALLERGY RELIEF 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-763
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorwhite (White to Off White) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code RX526
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10135-763-3030 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2022
2NDC:10135-763-9090 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2022
3NDC:10135-763-03300 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613410/01/2022
Labeler - Marlex Pharmaceuticals, Inc. (782540215)

Revised: 11/2023
Document Id: 09bac992-802d-5dee-e063-6394a90a7e0d
Set id: ec08a6ee-3d71-0fa9-e053-2995a90a9cb1
Version: 2
Effective Time: 20231109
 
Marlex Pharmaceuticals, Inc.