Label: LORATADINE ODT- loratadine tablet, orally disintegrating
- NDC Code(s): 68016-527-31
- Packager: Chain Drug Consortium, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated October 8, 2015
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- ACTIVE INGREDIENT (IN EACH TABLET)
Loratadine, USP 10 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 (1-800-222-1222).
- place 1 tablet on tongue; tablet disintegrates, with or without water
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
- Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet.
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
- store between 20° to 25° C (68° to 77° F). Protect from excessive moisture.
- keep in a dry place.
- use tablet immediately after opening individual blister.
- INACTIVE INGREDIENTS
aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarateClose
Keep the carton. It contains important information.
See end panel for expiration date.
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431Close
- PRINCIPAL DISPLAY PANEL
Original Prescription Strength
24 Hour Allergy Relief
Loratadine Orally Disintegrating Tablets, 10 mg
Indoor & Outdoor Allergies
No water needed. Melts in your mouth.
- Itchy, Watery Eyes
- Runny Nose
- Itchy Throat or Nose
For Adults and Children six years and older!
30 ORALLY DISINTEGRATING TABLETS
COMPARE TO THE ACTIVE INGREDIENT OF CLARITIN®REDITABS®†
*When taken as directed. See Drug Facts Panel.
†This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc. CLARITIN® and REDITABS® are registered trademarks of Schering Corporation.Close
- INGREDIENTS AND APPEARANCE
loratadine tablet, orally disintegrating
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-527 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 ASPARTAME (UNII: Z0H242BBR1) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) Product Characteristics Color white (white to off-white) Score no score Shape ROUND (flat faced beveled edge) Size 10mm Flavor STRAWBERRY, TUTTI FRUTTI, MINT Imprint Code RC17 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-527-31 30 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 ANDA ANDA077153 08/31/2007 Labeler - Chain Drug Consortium, LLC (101668460) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 051565745 MANUFACTURE(68016-527)