Label: LORATADINE tablet
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NDC Code(s):
50090-4300-0,
50090-4300-1,
50090-4300-3,
50090-4300-4, view more50090-4300-5, 50090-4300-6
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 16714-898
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 21, 2024
If you are a consumer or patient please visit this version.
- 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?
- HOW SUPPLIED
- Loratadine
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INGREDIENTS AND APPEARANCE
LORATADINE
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-4300(NDC:16714-898) 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:50090-4300-3 15 in 1 BOTTLE; Type 0: Not a Combination Product 05/16/2019 2 NDC:50090-4300-6 7 in 1 BOTTLE; Type 0: Not a Combination Product 05/16/2019 3 NDC:50090-4300-0 10 in 1 BOTTLE; Type 0: Not a Combination Product 05/16/2019 4 NDC:50090-4300-4 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/16/2019 5 NDC:50090-4300-5 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/16/2019 6 NDC:50090-4300-1 20 in 1 BOTTLE; Type 0: Not a Combination Product 05/16/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076301 02/20/2019 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-4300) , REPACK(50090-4300)