Label: LORATADINE tablet
- NDC Code(s): 63941-526-31, 63941-526-60, 63941-526-69
- Packager: Valu Merchandisers Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 28, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
- QUESTIONS?
-
PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton
COMPARE TO THE ACTIVE INGREDIENT IN CLARITIN®*
Best
Choice®Non-Drowsy†
ORIGINAL PRESCRIPTION STRENGTH
ALLERGY RELIEFLoratadine Tablets, USP 10 mg
ANTIHISTAMINE24 Hour Allergy Relief
Indoor & Outdoor AllergiesRelief of:
- Sneezing
- Itchy, Watery Eyes
- Runny Nose
- Itchy Throat or Nose
10 TABLETS
† When taken as directed. See Drug Facts Panel.
-
INGREDIENTS AND APPEARANCE
LORATADINE
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-526 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:63941-526-69 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 08/19/2003 2 NDC:63941-526-31 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 08/19/2003 3 NDC:63941-526-60 60 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 - Valu Merchandisers Company (868703513) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 051565745 manufacture(63941-526)