Label: LORATADINE tablet
- NDC Code(s): 56062-526-31, 56062-526-69, 56062-526-90
- Packager: Publix Super Markets Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 3, 2019
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
-
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
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton
NDC 56062-526-69
INDOOR & OUTDOOR ALLERGIES
24-HOURallergyrelief
LORATADINE TABLETS, USP 10 mg
ANTIHISTAMINE
Non-drowsy*
Relief of:
• Sneezing • Runny nose
• Itchy, watery eyes
• Itchy throat or nose10 TABLETS
*When taken as directed. See Drug Facts Panel.
ACTUAL SIZE
†Compare to the active
ingredient of Claritin® -
INGREDIENTS AND APPEARANCE
LORATADINE
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-526 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:56062-526-69 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 08/19/2003 2 NDC:56062-526-31 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 08/19/2003 3 NDC:56062-526-90 90 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 - Publix Super Markets Inc (006922009) Registrant - Sun Pharmaceutical Industries Inc. (146974886) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 051565745 manufacture(56062-526)