LORATADINE- loratadine capsule, liquid filled 
Bionpharma Inc.

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Drug Facts

Active ingredient (in each capsule)

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 capsule daily; not more than 1 capsule 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

FD&C blue no.1, gelatin, glycerin, hypromellose, hydrolyzed collagen, isopropyl alcohol, mannitol, medium chain mono- & di-glycerides, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

This product is not manufactured or distributed by the owners of Claritin® LIQUI-GELS®.

Blister carton contain the following:

THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Do not use if carton is open, or if individual blister unit is open or torn

Manufactured for:

Bionpharma Inc.

600 Alexander Road,

Princeton, NJ 08540

Principal Display Panel

5's Carton

LORATADINE 
loratadine capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-283
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW) (UNII: 5WE8P977RQ)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MANNITOL (UNII: 3OWL53L36A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize10mm
FlavorImprint Code L10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69452-283-191 in 1 CARTON03/20/2020
190 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:69452-283-25180 in 1 BOTTLE; Type 0: Not a Combination Product03/20/2020
3NDC:69452-283-171 in 1 CARTON08/26/2021
360 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20253803/20/2020
Labeler - Bionpharma Inc. (079637826)
Registrant - Bionpharma Inc. (079637826)
Establishment
NameAddressID/FEIBusiness Operations
Patheon Softgels Inc.002193829manufacture(69452-283)

Revised: 12/2022
Document Id: f0ffe026-a3b1-2ac7-e053-2a95a90a9c83
Set id: 4fa705fb-859e-4046-b153-a8338c50a97d
Version: 4
Effective Time: 20221229
 
Bionpharma Inc.