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NDC 62011-0371-01 health mart childrens allergy relief 5 mg/1 Details

health mart childrens allergy relief 5 mg/1

health mart childrens allergy relief is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services 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: 62011-0371-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	62011-0371
Product ID	62011-0371_ce44fbc4-2fc2-4b29-b6a2-e2d7ba4189f4
Associated GPIs
GCN Sequence Number	062340
GCN Sequence Number Description	loratadine TAB CHEW 5 MG ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	98118
HICL Sequence Number	007605
HICL Sequence Number Description	LORATADINE
Brand/Generic	Generic
Proprietary Name	health mart childrens allergy relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	loratadine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/1
Substance Name	LORATADINE
Labeler Name	Strategic Sourcing Services LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA210033
Listing Certified Through	2024-12-31

Package

Package Images

NDC 62011-0371-01 (62011037101)

Pricing Information
NDC Package Code	62011-0371-1
Billing NDC	62011037101
Package	30 BLISTER PACK in 1 CARTON (62011-0371-1) / 1 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Start Date	2019-08-16
NDC Exclude Flag	N
Price Per Unit	0.404
Pricing Unit	EA
Effective Date	2022-05-18
NDC Description	HM CHILD ALLERGY RLF 5 MG CHEW
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4
Classification for Rate Setting	G
As of Date	2022-11-23

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 3068b857-6d96-46b0-8c85-de231a976444 Details

Active ingredient (in each tablet)

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

•: chew or crush tablets completely before swallowing

adults and children 6 years and over	chew 2 tablets daily; not more than 2 tablets in 24 hours
children 2 to under 6 years of age	chew 1 tablet daily; not more than 1 tablet in 24 hours
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

•: phenylketonurics: contains phenylalanine 1.4 mg per tablet
•: do not use if blister unit is broken or torn
•: store between 20° to 25°C (68° to 77°F)

Inactive ingredients

artificial grape flavor, aspartame, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Children’s Claritin® Chewables active ingredient

NON-DROWSY*

Children’s Allergy Relief

Loratadine Chewable Tablets, 5 mg

Antihistamine

24 Hour

Relief of:

Sneezing - Runny Nose

Itchy, Watery Eyes - Itchy Throat or Nose

ACTUAL SIZE

Grape Flavored

Ages 2 years and Older

Indoor & Outdoor Allergies - Gluten Free

*When taken as directed. See Drug Facts Panel.

30 Chewable Tablets

INGREDIENTS AND APPEARANCE

HEALTH MART CHILDRENS ALLERGY RELIEF

loratadine tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62011-0371
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
ASPARTAME (UNII: Z0H242BBR1)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	PURPLE (light)	Score	no score
Shape	ROUND	Size	8mm
Flavor	GRAPE	Imprint Code	L3Y8
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62011-0371-1	30 in 1 CARTON	08/16/2019
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA210033	08/16/2019

Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 8/2020

Document Id: ce44fbc4-2fc2-4b29-b6a2-e2d7ba4189f4

Set id: 3068b857-6d96-46b0-8c85-de231a976444

Version: 2

Effective Time: 20200811