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NDC 11523-4330-03 Claritin 5 mg/1 Details

Claritin 5 mg/1

Claritin is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Bayer HealthCare 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: 11523-4330-03
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	11523-4330
Product ID	11523-4330_eb00777b-2fef-e655-e053-2995a90a3846
Associated GPIs	41550030000520
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	Claritin
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	Bayer HealthCare LLC.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA021891
Listing Certified Through	2024-12-31

Package

Package Images

NDC 11523-4330-03 (11523433003)

Pricing Information	N/A
NDC Package Code	11523-4330-3
Billing NDC	11523433003
Package	3 BLISTER PACK in 1 CARTON (11523-4330-3) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Start Date	2015-09-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 20938e05-bc3e-51aa-e054-00144ff88e88 Details

Drug Facts

Active Ingredients

Loratadine 5 mg

Purpose

Antihistamine

SPL UNCLASSIFIED SECTION

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

Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

AS a doctor before use if you have

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

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

SPL UNCLASSIFIED SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

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 1.9 mg per tablet
safety sealed: do not use if the individual blister unit imprinted with Children’s Claritin® is open or torn
store between 20° to 25°C (68° to 77°F)

SPL UNCLASSIFIED SECTION

aspartame, carmine, citric acid, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

SPL UNCLASSIFIED SECTION

1-800-CLARITIN

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

ages

2 years®

and older

Children's

Claritin®

Chewables

loratadine 5 mg/antihistamine

Indoor & Outdoor

Allergies

*When taken as directed.

See Drug Facts Panel

Non-Drowsy*

24 Hour Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Bubblegum

Flavored

Chewable Tablets

INGREDIENTS AND APPEARANCE

CLARITIN

loratadine tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11523-4330
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
ASPARTAME (UNII: Z0H242BBR1)

Product Characteristics
Color	pink (Light to Medium Pink with a Slightly and/or Mottled Appearance)	Score	no score
Shape	ROUND (Round (Flat Faced Beveled Edge))	Size	10mm
Flavor	BUBBLE GUM	Imprint Code	C
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11523-4330-1	1 in 1 CARTON	09/25/2015
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:11523-4330-3	3 in 1 CARTON	09/25/2015
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:11523-4330-4	4 in 1 CARTON	09/25/2015
3		10 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
NDA	NDA021891	09/25/2015

Labeler - Bayer HealthCare LLC. (112117283)

Revised: 10/2022

Document Id: eb00777b-2fef-e655-e053-2995a90a3846

Set id: 20938e05-bc3e-51aa-e054-00144ff88e88

Version: 7

Effective Time: 20221014

Search by Drug Name or NDC

NDC 11523-4330-03 Claritin 5 mg/1 Details

Claritin 5 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 11523-4330-03 (11523433003)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 20938e05-bc3e-51aa-e054-00144ff88e88 Details

Drug Facts

Active Ingredients

Purpose

SPL UNCLASSIFIED SECTION

Do Not Use

AS a doctor before use if you have

When using this product

Stop use and ask a doctor if

SPL UNCLASSIFIED SECTION

Keep out of reach of children

Directions

Other information

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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