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NDC 30142-0066-54 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 KROGER COMPANY. 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: 30142-0066-54
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	30142-0066
Product ID	30142-066_e4cdd8db-2b44-41b0-8f38-55c6dff1a9ab
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	TABLET
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	LORATADINE
Labeler Name	KROGER COMPANY
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA208314
Listing Certified Through	2024-12-31

Package

Package Images

NDC 30142-0066-54 (30142006654)

Pricing Information	N/A
NDC Package Code	30142-066-54
Billing NDC	30142006654
Package	1 BOTTLE in 1 CARTON (30142-066-54) / 70 TABLET in 1 BOTTLE
Marketing Start Date	2021-03-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b96831f5-5e75-c526-e053-2995a90a36ad 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?

1-800-632-6900

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

MADE IN INDIA

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Label (30 Tablets)

NDC 30142-066-09

Kroger®

Non-Drowsy*

Allergy Relief

24

HOUR

Loratadine Tablets USP

10 mg/Antihistamine

INDOOR & OUTDOOR

ALLERGIES

*When taken as directed. See Drug Facts Panel.

RELIEF OF:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

30 TABLETS

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

COMPARE TO the active ingredient of CLARITIN® TABLETS **See bottom panel

NDC 30142-066-09

Kroger®

Non-Drowsy*

Allergy Relief

Loratadine Tablets USP 10 mg/Antihistamine

INDOOR & OUTDOOR ALLERGIES

RELIEF OF: Sneezing; Runny Nose

Itchy, Watery Eyes; Itchy Throat or Nose

*When taken as directed. See Drug Facts Panel.

24

HOUR

actual

size L

30 TABLETS

INGREDIENTS AND APPEARANCE

LORATADINE

loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-066
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:30142-066-09	1 in 1 CARTON	03/15/2021
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:30142-066-54	1 in 1 CARTON	03/15/2021
2		70 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	03/15/2021

Labeler - KROGER COMPANY (006999528)

Registrant - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		650381903	ANALYSIS(30142-066) , MANUFACTURE(30142-066)

Revised: 4/2021

Document Id: e4cdd8db-2b44-41b0-8f38-55c6dff1a9ab

Set id: b96831f5-5e75-c526-e053-2995a90a36ad

Version: 3

Effective Time: 20210408