CLARITIN REDITABS- loratadine tablet, orally disintegrating

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 5 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

• place 1 tablet on tongue; tablet disintegrates, with or without water

• adults and children 6 years and over: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
• children under 6 years of age: ask a doctor
• consumers with liver or kidney disease: ask a doctor

Other information

• safety sealed: do not use if the individual blister unit imprinted with Claritin® RediTabs® is open or torn
• store between 20° to 25°C (68° to 77°F)
• use tablet immediately after opening individual blister
• complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration

Inactive ingredients

anhydrous citric acid, gelatin, mannitol, mint flavor

Questions or comments?

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

SPL UNCLASSIFIED SECTION

Distributed by MSD Consumer Care, Inc.,
PO Box 377, Memphis, TN 38151 USA,
a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ USA.

PRINCIPAL DISPLAY PANEL - 10 Tablet Carton

NDC: 11523-7202-3

Non-Drowsy*

Claritin ®

RediTabs ®

loratadine 5 mg/antihistamine

Indoor & Outdoor

Allergies

*When taken as directed. See Drug Facts Panel.

12

Hour

Relief of:

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat
  
  or Nose

No Water Needed

Melts in Your Mouth

10

ORALLY

DISINTEGRATING TABLETS

INGREDIENTS AND APPEARANCE

CLARITIN  REDITABS
loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7202
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	5 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GELATIN (UNII: 2G86QN327L)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (flat faced beveled edge)	Size	12mm
Flavor	MINT	Imprint Code	C5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7202-1	3 in 1 CARTON	12/12/2006
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 11523-7202-3	1 in 1 CARTON	12/12/2006
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021993	12/12/2006

Labeler - Bayer HealthCare LLC (112117283)