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

10 count carton

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

Carton box 45

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

Dump bin 1 Dump bin 2

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)

Non-Drowsy*Claritin ® loratadine tablets 10 mg/antihistamine

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

Non-Drowsy*Claritin ®
loratadine tablets 10 mg/antihistamine