Label: LORATADINE tablet
- NDC Code(s): 0904-6852-07, 0904-6852-60, 0904-6852-72, 0904-6852-89
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 10, 2022
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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 or comments?
-
Principal Display Panel
COMPARE TO the active ingredient of CLARITIN®
Non-Drowsy* - Allergy
Original Prescription Strength
*When taken as directed. See Drug Facts Panel.
Loratadine Tablets, 10 mg/Antihistamine
Indoor & Outdoor Allergies
24 HOUR
Actual Size
24 Hour Relief of:
Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose
100 Tablets
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INGREDIENTS AND APPEARANCE
LORATADINE
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6852 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 LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) Product Characteristics Color WHITE Score no score Shape OVAL Size 8mm Flavor Imprint Code L612 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-6852-60 1 in 1 CARTON 12/06/2018 1 100 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0904-6852-89 1 in 1 CARTON 04/08/2019 2 90 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0904-6852-07 30 in 1 CARTON 08/01/2019 3 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:0904-6852-72 1 in 1 CARTON 06/04/2019 4 300 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076301 12/06/2018 Labeler - Major Pharmaceuticals (191427277)