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NDC 30142-0062-24 Loratadine 5 mg/5mL Details

Loratadine 5 mg/5mL

Loratadine is a ORAL SOLUTION 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: 30142-0062-24
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	30142-0062
Product ID	30142-062_00345362-5d45-4ddc-8661-244992db84b0
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 Oral
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/5mL
Substance Name	LORATADINE
Labeler Name	KROGER COMPANY
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA208931
Listing Certified Through	2024-12-31

Package

Package Images

NDC 30142-0062-24 (30142006224)

Pricing Information	N/A
NDC Package Code	30142-062-24
Billing NDC	30142006224
Package	1 BOTTLE in 1 CARTON (30142-062-24) / 120 mL in 1 BOTTLE
Marketing Start Date	2021-03-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b963d83b-584f-c447-e053-2995a90ad973 Details

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Loratadine USP 5 mg

Purpose

Antihistamine

Uses

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

runny nose
sneezing
itchy, watery eyes
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

use only with enclosed dosing cup

adults and children 6 years and over	2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
children 2 to under 6 years of age	1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

each teaspoonful contains: sodium 6 mg
do not use if carton is opened, or if cap safety seal is broken or missing.
store at 20° to 25°C (68° to 77°F)

Inactive ingredients

artificial flavors, ascorbic acid, glycerin, maltitol, monobasic sodium phosphate monohydrate, phosphoric acid, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose.

Questions or comments?

1-800-632-6900

DISTRIBUTRD BY THE KROGER CO.

CINCINNATI, OHIO 45202

MADE IN INDIA

Code:TS/DRUGS/19/1993

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (120 mL Bottle)

NDC 30142-062-24

Kroger®

Ages 2 Years & Older

children's

Allergy Relief

Loratadine Oral

Solution USP,

5 mg/5 mL

Antihistamine

INDOOR & OUTDOOR

ALLERGIES

24 HOUR

DYE-FREE

Grape Flavor

4 FL OZ (120 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (120 mL)

COMPARE TO the active ingredient of

CHILDRENS'S CLARITIN® **See side panel

NDC 30142-062-24

Kroger®

Ages 2 Years & Older

Non-Drowsy*

children's

Allergy Relief

Loratadine Oral

Solution USP, 5 mg/5 mL

Antihistamine

INDOOR & OUTDOOR ALLERGIES

24 HOUR RELIEF OF:

Sneezing; Runny Nose;

Itchy,watery Eyes &

Itchy Throat or Nose

Contains sodium metabisulfite,

a sulfite that may cause

allergic-type reactions.

Dosing

Cup Included

DYE-FREE

Grape Flavor

4 FL OZ (120 mL)

* When taken as directed.

See Drug Facts Panel.

INGREDIENTS AND APPEARANCE

LORATADINE

loratadine oral solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-062
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
GRAPE (UNII: 6X543N684K)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
PHOSPHORIC ACID (UNII: E4GA8884NN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	YELLOW (colorless to light yellow)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:30142-062-24	1 in 1 CARTON	03/15/2021
1		120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208931	03/15/2021

Labeler - KROGER COMPANY (006999528)

Registrant - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		918917642	ANALYSIS(30142-062) , MANUFACTURE(30142-062)

Revised: 4/2021

Document Id: 00345362-5d45-4ddc-8661-244992db84b0

Set id: b963d83b-584f-c447-e053-2995a90ad973

Version: 3

Effective Time: 20210419