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NDC 11523-7160-02 Claritin 10 mg/1 Details

Claritin 10 mg/1

Claritin is a ORAL TABLET 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: 11523-7160-02
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	11523-7160
Product ID	11523-7160_eaffeda1-d462-bb0b-e053-2995a90ab990
Associated GPIs	41550030000320
GCN Sequence Number	018698
GCN Sequence Number Description	loratadine TABLET 10 MG ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	60563
HICL Sequence Number	007605
HICL Sequence Number Description	LORATADINE
Brand/Generic	Brand
Proprietary Name	Claritin
Proprietary Name Suffix	n/a
Non-Proprietary Name	Loratadine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	10
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	NDA019658
Listing Certified Through	2024-12-31

Package

Package Images

NDC 11523-7160-02 (11523716002)

Pricing Information	N/A
NDC Package Code	11523-7160-2
Billing NDC	11523716002
Package	1 BLISTER PACK in 1 CARTON (11523-7160-2) / 10 TABLET in 1 BLISTER PACK
Marketing Start Date	1993-04-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 660ac9df-f1b1-4c89-94dd-9fae0a013f3c Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Loratadine 10 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.

Directions

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

Other information (Blister foil units)

safety sealed: do not use if the individual blister unit imprinted with Claritin ® is open or torn
store between 20° to 25°C (68° to 77°F)
protect from excessive moisture

Other information (Bottles)

Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
store between 20° to 25°C (68° to 77°F)

Inactive ingredients

corn starch, lactose monohydrate, magnesium stearate

Questions or comments?

1-800-CLARITIN (1-800-252-7484) or www.claritin.com

PRINCIPAL DISPLAY PANEL - 10 Tablet Carton

Original Prescription

Strength

Non-Drowsy*

Claritin®

loratadine tablets 10 mg/antihistamine

24 Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Indoor & Outdoor

Allergies

*When taken as directed.

See Drug Facts Panel.

10 Tablets

PRINCIPAL DISPLAY PANEL - 45 Count Window Box

Original Prescription Strength

Non-Drowsy *

Claritin ®

loratadine tablets 10 mg/antihistamine

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Indoor & Outdoor

Allergies

* When taken as directed.

See Drug Facts Panel.

45 TABLETS

PRINCIPAL DISPLAY PANEL - 50 Tablet Carton

Non-Drowsy*

Claritin®

loratadine tablets 10 mg/antihistamine

24 Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Indoor & Outdoor

Allergies

*When taken as directed.

See Drug Facts Panel.

50 1-Count Pouches

Total 50 Tablets

INGREDIENTS AND APPEARANCE

CLARITIN

loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11523-7237
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	458;Claritin10
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11523-7237-1	1 in 1 CARTON	04/12/1993
1		45 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:11523-7237-3	7 in 1 CARTON	08/12/1993
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:11523-7237-5	1 in 1 BLISTER PACK	04/12/1993
3		90 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:11523-7237-6	3 in 1 CARTON	04/12/1993
4		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC:11523-7237-7	4 in 1 CARTON	04/12/1993
5		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC:11523-7237-8	1 in 1 CARTON	04/12/1993
6		108 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC:11523-7237-9	1 in 1 CARTON	10/05/2017
7		90 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA019658	04/12/1993

CLARITIN

loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11523-7160
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	458;Claritin10
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11523-7160-1	1 in 1 CARTON	04/12/1993
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:11523-7160-2	1 in 1 CARTON	04/12/1993
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:11523-7160-3	2 in 1 CARTON	04/12/1993
3		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:11523-7160-5	3 in 1 CARTON	04/12/1993
4		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC:11523-7160-6	1 in 1 CARTON	04/12/1993
5		2 in 1 POUCH; Type 0: Not a Combination Product
6	NDC:11523-7160-7	1 in 1 POUCH	04/12/1993
6		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
7	NDC:11523-7160-9	1 in 1 CARTON	04/12/1993
7		60 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC:11523-7160-8	1 in 1 CARTON	09/01/2016
8		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA019658	04/12/1993

CLARITIN

loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11523-1527
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	458;Claritin10
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11523-1527-1	50 in 1 BOX	04/12/1993
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC:11523-1527-2	50 in 1 BOX	04/12/1993
2		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA019658	04/12/1993

CLARITIN

loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11523-4359
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	458;Claritin10
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11523-4359-1	1 in 1 CARTON	04/12/1993
1		40 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:11523-4359-2	1 in 1 CARTON	04/12/1993
2		100 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:11523-4359-3	1 in 1 CARTON	11/01/2017
3		90 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:11523-4359-4	1 in 1 CARTON	02/15/2019
4		55 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:11523-4359-5	1 in 1 CARTON	02/15/2019
5		85 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:11523-4359-6	1 in 1 CARTON	12/01/2019
6		110 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC:11523-4359-8	2 in 1 BLISTER PACK	04/12/1993
7		60 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC:11523-4359-9	1 in 1 CARTON	12/01/2019
8		35 in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC:11523-4359-7	1 in 1 BLISTER PACK	04/12/1993
9		115 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA019658	04/12/1993

Labeler - Bayer HealthCare LLC. (112117283)

Revised: 10/2022

Document Id: eaffeda1-d462-bb0b-e053-2995a90ab990

Set id: 660ac9df-f1b1-4c89-94dd-9fae0a013f3c

Version: 11

Effective Time: 20221014

Search by Drug Name or NDC

NDC 11523-7160-02 Claritin 10 mg/1 Details

Claritin 10 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 11523-7160-02 (11523716002)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 660ac9df-f1b1-4c89-94dd-9fae0a013f3c Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

Purpose

Uses

Warnings

Directions

Other information (Blister foil units)

Other information (Bottles)

Inactive ingredients

Questions or comments?

PRINCIPAL DISPLAY PANEL - 10 Tablet Carton

PRINCIPAL DISPLAY PANEL - 45 Count Window Box

PRINCIPAL DISPLAY PANEL - 50 Tablet Carton

INGREDIENTS AND APPEARANCE

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