LORATADINE- loratadine tablet 
PLD Acquisitions LLC DBA Avéma Pharma Solutions

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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 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.

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, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9 AM-5 PM EST

Principal Display Panel

†Compare to the active ingredient in Claritin®

Loratadine tablets, USP

Antihistamine

10 mg

Non-drowsy*

Indoor & outdoor allergies

24-hour relief of

100 Tablets

*When taken as directed. See Drug Facts panel

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Claritin®

Manufactured by:

Avema Pharm Solutions

10400 NW 29th Terrace, Miami, FL 33172

Package Label

loratadine 10 mg

Loratadine 10 mg Tablets

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-0753
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
ShapeROUNDSize6mm
FlavorImprint Code GG296
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63548-0753-330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/30/2018
2NDC:63548-0753-1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/30/2018
3NDC:63548-0753-0300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07520910/30/2018
Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)

Revised: 5/2023
Document Id: c24222bc-72ef-4c15-b7c2-9401fe5f40a6
Set id: 2edb53f8-7661-4e54-bb50-e03078bae3bf
Version: 6
Effective Time: 20230504
 
PLD Acquisitions LLC DBA Avéma Pharma Solutions