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NDC 69452-0211-16 LORATADINE 10 mg/1 Details

LORATADINE 10 mg/1

LORATADINE is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Bionpharma Inc.. The primary component is LORATADINE.

MedlinePlus Drug Summary

Loratadine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and other allergies. These symptoms include sneezing, runny nose, and itchy eyes, nose, or throat. Loratadine is also used to treat itching and redness caused by hives. However, loratadine does not prevent hives or other allergic skin reactions. Loratadine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Loratadine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of loratadine alone. If you are taking the loratadine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.

Related Packages: 69452-0211-16
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	69452-0211
Product ID	69452-211_932678d1-e6bf-4154-ac00-b6b9c9fbd16e
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	LORATADINE
Proprietary Name Suffix	n/a
Non-Proprietary Name	LORATADINE
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	LORATADINE
Labeler Name	Bionpharma Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA202538
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69452-0211-16 (69452021116)

Pricing Information	N/A
NDC Package Code	69452-211-16
Billing NDC	69452021116
Package	1 BOTTLE in 1 CARTON (69452-211-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Start Date	2019-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 59bebce3-2b82-4521-a796-2d4c83bcf669 Details

Active ingredient (in each capsule)

Loratadine 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

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

Tamper-evident: do not use if foil seal under cap, printed with “Sealed for your protection” is missing, open or broken. (For Bottle Labels and Cartons)
Safety sealed: do not use if individual blister unit printed with Loratadine Capsule, 10 mg is open or torn. (For Blister Carton)
store between 20° to 25°C (68° to 77°F)
protect from freezing

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

INGREDIENTS AND APPEARANCE

LORATADINE

loratadine capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69452-211
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	blue	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	446
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69452-211-03	1 in 1 CARTON	03/01/2019
1		5 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:69452-211-16	1 in 1 CARTON	03/01/2019
2		50 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:69452-211-26	1 in 1 CARTON	03/01/2019
3		200 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:69452-211-07	1 in 1 CARTON	03/01/2019
4		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202538	03/01/2019

Labeler - Bionpharma Inc. (079637826)

Registrant - Bionpharma Inc. (079637826)

Name	Address	ID/FEI	Business Operations
Establishment
Patheon Softgels Inc.		002193829	manufacture(69452-211)

Revised: 1/2019

Document Id: 932678d1-e6bf-4154-ac00-b6b9c9fbd16e

Set id: 59bebce3-2b82-4521-a796-2d4c83bcf669

Version: 2

Effective Time: 20190108