CLARITIN- loratadine tablet

Claritin by

Drug Labeling and Warnings

Claritin by is a Otc medication manufactured, distributed, or labeled by Select Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Loratadine, USP 10 mg

Purpose

Antihistamine

Uses

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

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 (1-800-222-1222).

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

• store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature)

Inactive ingredients

lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

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

SPL UNCLASSIFIED SECTION

Dist by: Bayer HealthCare LLC
Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 10 mg Pouch Blister Pack

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

Original Prescription Strength

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.

1 Tablet

INGREDIENTS AND APPEARANCE

CLARITIN 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52904-630(NDC:11523-7160)
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
lactose monohydrate (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)
magnesium stearate (UNII: 70097M6I30)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52904-630-03	1 in 1 BLISTER PACK	12/15/2011
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 52904-630-20	20 in 1 CARTON	12/15/2011
2		1 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 52904-630-25	25 in 1 CARTON	12/15/2011
3		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019658	12/15/2011

Labeler - Select Corporation (053805599)