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NDC 43353-0259-30 Loratadine 10 mg/1 Details

Loratadine 10 mg/1

Loratadine is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. 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: 43353-0259-30
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	43353-0259
Product ID	43353-259_7b7e9faa-ff3d-4886-a07e-63775e66f9f9
Associated GPIs	41550030000320
GCN Sequence Number	018698
GCN Sequence Number Description	loratadine TABLET 10 MG ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	60563
HICL Sequence Number	007605
HICL Sequence Number Description	LORATADINE
Brand/Generic	Generic
Proprietary Name	Loratadine
Proprietary Name Suffix	antihistamine
Non-Proprietary Name	Loratadine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	LORATADINE
Labeler Name	Aphena Pharma Solutions - Tennessee, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076301
Listing Certified Through	2024-12-31

Package

Package Images

NDC 43353-0259-30 (43353025930)

Pricing Information	N/A
NDC Package Code	43353-259-30
Billing NDC	43353025930
Package	30 TABLET in 1 BOTTLE (43353-259-30)
Marketing Start Date	2017-01-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a2c92766-df4e-4414-9c42-e18bcf9db6b4 Details

Active ingredient (in each tablet)

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. (1-800-222-1222)

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

•: do not use if printed foil under cap is broken or missing
•: store between 20° to 25°C (68° to 77°F)

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-800-719-9260

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count	10 mg
30	43353-259-30
90	43353-259-60
3000	43353-259-18
9000	43353-259-09

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506

20221018JK

PRINCIPAL DISPLAY PANEL - 10 mg

NDC 43353-259 - Loratadine 10 mg Tablets

INGREDIENTS AND APPEARANCE

LORATADINE ANTIHISTAMINE

loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43353-259(NDC:45802-650)
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	8mm
Flavor		Imprint Code	L612
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43353-259-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/17/2017
2	NDC:43353-259-60	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/23/2016
3	NDC:43353-259-18	3000 in 1 BOTTLE; Type 0: Not a Combination Product	10/17/2022
4	NDC:43353-259-09	9000 in 1 BOTTLE; Type 0: Not a Combination Product	09/08/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076301	10/15/2008

Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)

Name	Address	ID/FEI	Business Operations
Establishment
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(43353-259)

Revised: 10/2022

Document Id: 7b7e9faa-ff3d-4886-a07e-63775e66f9f9

Set id: a2c92766-df4e-4414-9c42-e18bcf9db6b4

Version: 4

Effective Time: 20221018