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NDC 41250-0629-39 childrens allergy relief 5 mg/1 Details

childrens allergy relief 5 mg/1

childrens allergy relief is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Meijer Distribution Inc. 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: 41250-0629-39
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	41250-0629
Product ID	41250-629_f880d534-c56a-4cd3-acb8-170e0346f567
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	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	Meijer Distribution Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA210033
Listing Certified Through	2024-12-31

Package

Package Images

NDC 41250-0629-39 (41250062939)

Pricing Information	N/A
NDC Package Code	41250-629-39
Billing NDC	41250062939
Package	30 BLISTER PACK in 1 CARTON (41250-629-39) / 1 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Start Date	2019-08-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b27f0bd0-4e61-4498-b5b7-54ae31f637f3 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

Package/Label Principal Display Panel

Compare to Children’s Claritin® active ingredient

For Ages 2 Years And Older

NON-DROWSY* | CHILDREN’S

allergy relief

Loratadine Chewable Tablets, 5 mg

Antihistamine

INDOOR & OUTDOOR ALLERGIES

24 HOUR RELIEF OF:

Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose

30 Chewable Tablets | actual size

Grape Flavor

*When taken as directed. See Drug Facts Panel.

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY RELIEF

loratadine tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-629
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:41250-629-39	30 in 1 CARTON	08/27/2019
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	08/27/2019

Labeler - Meijer Distribution Inc (006959555)

Revised: 6/2020

Document Id: f880d534-c56a-4cd3-acb8-170e0346f567

Set id: b27f0bd0-4e61-4498-b5b7-54ae31f637f3

Version: 3

Effective Time: 20200611