LORATADINE ALLERGY RELIEF- loratadine tablet 
PD-Rx 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

Questions?

call 1-800-406-7984

PRINCIPAL DISPLAY PANEL - 10 mg Tablet

55289728 Label
LORATADINE ALLERGY RELIEF 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55289-728(NDC:51660-526)
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:55289-728-1010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/2020
2NDC:55289-728-1515 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2021
3NDC:55289-728-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2021
4NDC:55289-728-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/06/2018
5NDC:55289-728-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/18/2023
6NDC:55289-728-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/06/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613411/01/2017
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIBusiness Operations
PD-Rx Pharmaceuticals, Inc.156893695repack(55289-728)

Revised: 3/2024
Document Id: 137d424e-c55c-13fb-e063-6394a90a1e97
Set id: 7127b39d-3686-4249-b720-43c02b4c4654
Version: 16
Effective Time: 20240312
 
PD-Rx Pharmaceuticals, Inc.