CLARITIN- loratadine tablet

Drug Details [pdf]

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)

Trademark Results [Claritin]

Mark Image Registration \| Serial	Company Trademark Application Date
CLARITIN 86896888 not registered Dead/Abandoned	Bayer HealthCare LLC 2016-02-04
CLARITIN 85755081 4467572 Live/Registered	BAYER HEALTHCARE LLC 2012-10-16
CLARITIN 85114219 4129334 Live/Registered	BAYER HEALTHCARE LLC 2010-08-24
CLARITIN 85114214 4129333 Live/Registered	BAYER HEALTHCARE LLC 2010-08-24
CLARITIN 77802517 not registered Dead/Abandoned	Schering Corporation 2009-08-12
CLARITIN 77802516 4026607 Live/Registered	BAYER HEALTHCARE LLC 2009-08-12
CLARITIN 77802513 not registered Dead/Abandoned	MSD CONSUMER CARE, INC. 2009-08-12
CLARITIN 77802511 4019978 Live/Registered	BAYER HEALTHCARE LLC 2009-08-12
CLARITIN 77438652 3621772 Live/Registered	BAYER HEALTHCARE LLC 2008-04-03
CLARITIN 77224346 not registered Dead/Abandoned	Schering Corporation 2007-07-09
CLARITIN 77224345 not registered Dead/Abandoned	Schering Corporation 2007-07-09
CLARITIN 77222203 not registered Dead/Abandoned	Schering Corporation 2007-07-05

CLARITIN- loratadine tablet

Claritin by

Drug Labeling and Warnings

Drug Details [pdf]

Trademark Results [Claritin]

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