ALLERVARX- loratadine tablet, orally disintegrating 
Innovus Pharmaceuticals, Inc.

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Allervarx Loratadine Orally Disintegrating Tablets USP

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.

Directions

 adults and children 6 years and over

1 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

anhydrous citric acid, mannitol, peppermint flavor, polysorbate 80, pullulan

Questions or comments?

1-888-278-1784 - Our Medical Information center shall operate between 9:00 AM to 5:00 PM EST from Monday through Friday (business hours). Queries received outside business hours shall reach voice mail and shall be attended on next business day.

image description

ALLERVARX 
loratadine tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57483-950
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorMINTImprint Code T10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57483-950-103 in 1 CARTON05/30/2022
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21329405/30/2022
Labeler - Innovus Pharmaceuticals, Inc. (962507187)
Establishment
NameAddressID/FEIBusiness Operations
Tenshi Kaizen Pvt Ltd675478488manufacture(57483-950) , pack(57483-950) , analysis(57483-950)

Revised: 5/2022
Document Id: 41da41be-9966-4fff-9064-e9817ccbd5dd
Set id: 885e81ae-5ea3-4d14-8666-8c2698767014
Version: 1
Effective Time: 20220530
 
Innovus Pharmaceuticals, Inc.