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?

1-888-235-2466

**This product in not manufactured or distributed by Bayer, owner of the registered trademark Claritin® and Catalent Pharma Solutions, Inc, owner of the registered trademark LIQUI-GELS®.

Manufactured for:

Bionpharma Inc.

600 Alexander Road,

Princeton, NJ 08540

Rev # 07/17

Principal Display Panel

NDC 69452-211-03

Compare to the active ingredient in Claritin® Liqui-Gels®**

Original Prescription Strenght

Non-Drowsy*

Loratadine Capsules, 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 hour

Relief of:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

5 LIQUID-FILLED CAPSULES

*When taken as directed. See Drug Facts Panel

Do not use if carton is open, or if foil inner seal on bottle is broken

5's Carton

LORATADINE 
loratadine capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-211
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
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 446
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69452-211-031 in 1 CARTON03/01/2019
15 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69452-211-161 in 1 CARTON03/01/2019
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:69452-211-261 in 1 CARTON03/01/2019
3200 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:69452-211-071 in 1 CARTON03/01/2019
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20253803/01/2019
Labeler - Bionpharma Inc. (079637826)
Registrant - Bionpharma Inc. (079637826)
Establishment
NameAddressID/FEIBusiness Operations
Patheon Softgels Inc.002193829manufacture(69452-211)

Revised: 1/2019
Document Id: 932678d1-e6bf-4154-ac00-b6b9c9fbd16e
Set id: 59bebce3-2b82-4521-a796-2d4c83bcf669
Version: 2
Effective Time: 20190108
 
Bionpharma Inc.