Label: CLARITIN REDITABS- loratadine tablet, orally disintegrating
- NDC Code(s): 11523-7202-1, 11523-7202-3
- Packager: MSD Consumer Care, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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 DEA Schedule 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 1 10 in 1 BLISTER PACK 2 NDC:11523-7202-3 1 in 1 CARTON 2 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021993 12/12/2006 Labeler - MSD Consumer Care, Inc. (968091715)