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NDC 46122-0423-26 Childrens Loratadine 5 mg/5mL Details

Childrens Loratadine 5 mg/5mL

Childrens Loratadine is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by AmerisourceBergen. 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: 46122-0423-26
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	46122-0423
Product ID	46122-423_f8905ca0-2fa9-422e-a42d-7d2b99a07775
Associated GPIs	41550030001220
GCN Sequence Number	018697
GCN Sequence Number Description	loratadine SOLUTION 5 MG/5 ML ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	60562
HICL Sequence Number	007605
HICL Sequence Number Description	LORATADINE
Brand/Generic	Generic
Proprietary Name	Childrens Loratadine
Proprietary Name Suffix	Sugar Free
Non-Proprietary Name	Loratadine
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/5mL
Substance Name	LORATADINE
Labeler Name	AmerisourceBergen
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076805
Listing Certified Through	2024-12-31

Package

Package Images

NDC 46122-0423-26 (46122042326)

Pricing Information
NDC Package Code	46122-423-26
Billing NDC	46122042326
Package	1 BOTTLE in 1 CARTON (46122-423-26) / 120 mL in 1 BOTTLE
Marketing Start Date	2017-10-06
NDC Exclude Flag	N
Price Per Unit	0.04249
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	CHILD LORATADINE 5 MG/5 ML SOL
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 311733b1-7de7-486d-bb63-5d6933f0d543 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Loratadine 5 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

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

do not use if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing.
see bottom panel for lot number and expiration date
store between 20° and 25°C (68° and 77°F)

Inactive ingredients

butylated hydroxyanisole, glycerin, grape flavor, maltitol solution, masking agent, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sorbitol solution, sucralose powder.

Questions?

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed By AmerisourceBergen

1300 Morris Drive

Chesterbrook, PA 19087

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC 46122-423-26

Compare to

Children's Claritin®

active ingredient*

GOOD

NEIGHBOR

PHARMACY®

CHILDREN'S

Loratadine

Oral Solution

USP, 5 mg/5 mL

(Antihistamine) Allergy

Dye Free, Sugar Free

Grape Flavor

Indoor & Outdoor Allergies

24 Hour Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Non-Drowsy†

Ages 2 years and older

†When taken as directed.

See Drug Facts Panel.

Dosing Cup Enclosed

4 fl oz

(120 mL)

Principal Display Panel - 120 mL Bottle Carton

INGREDIENTS AND APPEARANCE

CHILDRENS LORATADINE SUGAR FREE

loratadine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46122-423
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
butylated hydroxyanisole (UNII: REK4960K2U)
glycerin (UNII: PDC6A3C0OX)
sorbitol (UNII: 506T60A25R)
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)
phosphoric acid (UNII: E4GA8884NN)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sodium phosphate, monobasic, dihydrate (UNII: 5QWK665956)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:46122-423-26	1 in 1 CARTON	10/06/2017
1		120 mL 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	ANDA076805	03/17/2017

Labeler - AmerisourceBergen (007914906)

Revised: 12/2017

Document Id: f8905ca0-2fa9-422e-a42d-7d2b99a07775

Set id: 311733b1-7de7-486d-bb63-5d6933f0d543

Version: 1

Effective Time: 20171215

Search by Drug Name or NDC

NDC 46122-0423-26 Childrens Loratadine 5 mg/5mL Details

Childrens Loratadine 5 mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 46122-0423-26 (46122042326)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 311733b1-7de7-486d-bb63-5d6933f0d543 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each 5 mL teaspoonful)

Purpose

Uses

Warnings

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

INGREDIENTS AND APPEARANCE

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