Label: ALLERGY RELIEF NON DROWSY- loratadine tablet
-
NDC Code(s):
50090-5067-0,
50090-5067-1,
50090-5067-3,
50090-5067-4, view more50090-5067-5, 50090-5067-6
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 69230-317
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 6, 2023
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
-
INGREDIENTS AND APPEARANCE
ALLERGY RELIEF NON DROWSY
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-5067(NDC:69230-317) 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) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color white Score no score Shape ROUND Size 6mm Flavor Imprint Code 439 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-5067-3 15 in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2020 2 NDC:50090-5067-5 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2020 3 NDC:50090-5067-0 10 in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2020 4 NDC:50090-5067-4 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2020 5 NDC:50090-5067-6 7 in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2020 6 NDC:50090-5067-1 20 in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075209 12/27/2019 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-5067) , REPACK(50090-5067)