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NDC 58602-0702-84 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 Aurohealth 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: 58602-0702-84
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	58602-0702
Product ID	58602-702_94169799-0508-439b-93c5-132b9e6ae767
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	n/a
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	Aurohealth LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA208314
Listing Certified Through	2024-12-31

Package

Package Images

NDC 58602-0702-84 (58602070284)

Pricing Information	N/A
NDC Package Code	58602-702-84
Billing NDC	58602070284
Package	3 BLISTER PACK in 1 CARTON (58602-702-84) / 10 TABLET in 1 BLISTER PACK
Marketing Start Date	2018-04-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 196da80c-3dbb-40c7-ac93-8a57d6acb1c3 Details

Drug Facts

Active ingredient (in each tablet)

Loratadine USP 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 (1-800-222-1222) 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 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
store at 20° to 25°C (68° to 77°F)
protect from excessive moisture

Inactive ingredients

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

Questions or comments?

call 1-855-274-4122

Distributed by: AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (45 Tablets Bottle)

NDC 58602-702-17

Non-Drowsy*

Loratadine

Tablets USP 10 mg

Antihistamine

24 Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Indoor & Outdoor

Allergies

*When taken as directed.

See Drug Facts Panel. 45 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (45 Tablets)

NDC 58602-702-17

#Compare to the active

ingredient in claritin®

Non-Drowsy*

Loratadine

Tablets USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

*When taken as directed

See Drug Facts Panel. 45 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (30 Tablets)

NDC 58602-702-84

#Compare to the active

ingredient in claritin®

Non-Drowsy*

Loratadine

Tablets USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

*When taken as directed.

See Drug Facts Panel.

30 Tablets

INGREDIENTS AND APPEARANCE

LORATADINE

loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58602-702
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)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (White to Off-white)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	39;L
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58602-702-17	1 in 1 CARTON	04/16/2018
1		45 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:58602-702-15	1 in 1 CARTON	04/16/2018
2		60 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:58602-702-19	1 in 1 CARTON	04/16/2018
3		90 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:58602-702-81	1 in 1 CARTON	04/16/2018
4		108 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:58602-702-32	1 in 1 CARTON	04/16/2018
5		180 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:58602-702-60	1 in 1 CARTON	04/16/2018
6		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
7	NDC:58602-702-83	1 in 1 CARTON	04/16/2018
7		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
8	NDC:58602-702-67	2 in 1 CARTON	04/16/2018
8		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
9	NDC:58602-702-84	3 in 1 CARTON	04/16/2018
9		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
10	NDC:58602-702-05	5 in 1 CARTON	04/16/2018
10		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
11	NDC:58602-702-09	1 in 1 CARTON	05/03/2019
11		30 in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC:58602-702-38	1 in 1 CARTON	05/03/2019
12		300 in 1 BOTTLE; Type 0: Not a Combination Product
13	NDC:58602-702-39	1 in 1 CARTON	05/03/2019
13		365 in 1 BOTTLE; Type 0: Not a Combination Product
14	NDC:58602-702-44	1 in 1 CARTON	07/26/2019
14		400 in 1 BOTTLE; Type 0: Not a Combination Product
15	NDC:58602-702-54	1 in 1 CARTON	10/04/2019
15		70 in 1 BOTTLE; Type 0: Not a Combination Product
16	NDC:58602-702-23	1 in 1 CARTON	10/04/2019
16		120 in 1 BOTTLE; Type 0: Not a Combination Product
17	NDC:58602-702-40	1 in 1 CARTON	11/28/2019
17		500 in 1 BOTTLE; Type 0: Not a Combination Product
18	NDC:58602-702-21	1 in 1 CARTON	12/23/2019
18		100 in 1 BOTTLE; Type 0: Not a Combination Product
19	NDC:58602-702-04	10 in 1 CARTON	02/10/2020
19		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
20	NDC:58602-702-29	1 in 1 CARTON	08/13/2020
20		150 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208314	04/16/2018

Labeler - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		650381903	ANALYSIS(58602-702) , MANUFACTURE(58602-702)

Revised: 8/2020

Document Id: 94169799-0508-439b-93c5-132b9e6ae767

Set id: 196da80c-3dbb-40c7-ac93-8a57d6acb1c3

Version: 10

Effective Time: 20200813