Label: LORATADINE ALLERGY RELIEF- loratadine tablet
- NDC Code(s): 67091-245-10, 67091-246-30
- Packager: WinCo Foods, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 29, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
-
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 Tablet Blister Pack Carton
*Compare to the active ingredient in CLARITIN®
†When taken as directed. See Drug Facts Panel.WinCo™
FOODS24 HOUR
NON-DROWSY†Allergy Relief
Indoor & Outdoor Allergies
LORATADINE TABLETS,
USP 10 mg/ANTIHISTAMINEOriginal
Prescription StrengthRelief of: Sneezing,
Runny Nose,
Itchy, Watery Eyes &
Itchy Throat or Nose10
Tablets -
PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton
*Compare to the active ingredient in CLARITIN®
†When taken as directed. See Drug Facts Panel.WinCo™
FOODS24 HOUR
NON-DROWSY†Allergy Relief
Indoor & Outdoor Allergies
LORATADINE TABLETS,
USP 10 mg/ANTIHISTAMINEOriginal
Prescription StrengthRelief of: Sneezing,
Runny Nose,
Itchy, Watery Eyes &
Itchy Throat or Nose30
Tablets -
INGREDIENTS AND APPEARANCE
LORATADINE ALLERGY RELIEF
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-245 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:67091-245-10 10 in 1 CARTON 01/08/2015 1 1 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 ANDA076134 08/28/2003 LORATADINE ALLERGY RELIEF
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-246 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:67091-246-30 30 in 1 CARTON 01/08/2015 1 1 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 ANDA076134 08/28/2003 Labeler - WinCo Foods, LLC (056098817) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 051565745 MANUFACTURE(67091-245, 67091-246)