CLARITIN- loratadine tablet

Claritin by

Drug Labeling and Warnings

Claritin by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC. Drug facts, warnings, and ingredients follow.

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 (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)

Other information (Blister foil units)

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

Inactive ingredients

corn starch, lactose monohydrate, magnesium stearate

Questions of comments?

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

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle 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.

70 TABLETS

INGREDIENTS AND APPEARANCE

CLARITIN 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-6655
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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;Claritin;10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-6655-1	1 in 1 POUCH	04/12/1993
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 11523-6655-2	1 in 1 CARTON	04/12/1993
2		70 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 11523-6655-3	2 in 1 BLISTER PACK	04/12/1993
3		45 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 11523-6655-4	1 in 1 BLISTER PACK	04/12/1993
4		105 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 11523-6655-6	1 in 1 BLISTER PACK	04/12/1993
5		105 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 11523-6655-7	25 in 1 BOX	04/12/1993
6		1 in 1 POUCH; Type 0: Not a Combination Product
7	NDC: 11523-6655-9	1 in 1 CARTON	04/12/1993
7		80 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 11523-6655-8	1 in 1 CARTON	04/12/1993
8		30 in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 11523-6655-5	1 in 1 CARTON	04/12/1993
9		60 in 1 BOTTLE; Type 0: Not a Combination Product

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

Labeler - Bayer HealthCare LLC (112117283)