Label: LORATADINE tablet
- NDC Code(s): 63868-151-01, 63868-151-10, 63868-151-30
- Packager: Chain Drug Marketing Association Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 27, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
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.
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton
QUALITY
CHOICENDC 63868-151-30
†Compare to
Active Ingredient in
CLARITIN®Original Prescription Strength
Allergy Relief
Loratadine Tablets, USP
10 mg | AntihistamineIndoor & Outdoor Allergies
Relief of:
Sneezing | Runny Nose
Itchy, Watery Eyes | Itchy Throat or Nose24 Hour Allergy Relief | Non-Drowsy*
30 Tablets
*When taken as directed. See Drug Facts Panel.
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INGREDIENTS AND APPEARANCE
LORATADINE
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-151 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 STARCH, CORN (UNII: O8232NY3SJ) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white (White to Off-White) Score no score Shape ROUND Size 6mm Flavor Imprint Code RX526 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-151-10 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 08/19/2003 2 NDC:63868-151-30 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 08/19/2003 3 NDC:63868-151-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/19/2003 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076134 08/19/2003 Labeler - Chain Drug Marketing Association Inc. (011920774) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 051565745 manufacture(63868-151)