Label: CLARITIN REDITABS- loratadine tablet, orally disintegrating
- NDC Code(s): 11523-7202-1, 11523-7202-3
- Packager: Bayer HealthCare LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated February 10, 2017
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
Loratadine 5 mgClose
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- itching of the nose or throat
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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- 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 flavorClose
- Questions or comments?
1-800-CLARITIN (1-800-252-7484) or www.claritin.comClose
- SPL UNCLASSIFIED SECTION
Distributed by MSD Consumer Care, Inc.,Close
PO Box 377, Memphis, TN 38151 USA,
a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ USA.
- PRINCIPAL DISPLAY PANEL - 10 Tablet Carton
loratadine 5 mg/antihistamine
Indoor & Outdoor
*When taken as directed. See Drug Facts Panel.
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat
No Water Needed
Melts in Your Mouth
- INGREDIENTS AND APPEARANCE
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)