Label: ALLERGY RELIEF- loratadine tablet
- NDC Code(s): 50090-6164-0, 50090-6164-4, 50090-6164-5
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 57896-658
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 20, 2022
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
Do not use if you have ever had an allergic reaction to this
product or any of its ingredients.
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.
Stop use and ask a doctor if an allergic reaction to this
product occurs. Seek medical help right away.
If pregnant or breast-feeding, ask a health professional before use.
- Directions
- Other information
- Inactive ingredients
- HOW SUPPLIED
- loratadine
-
INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-6164(NDC:57896-658) 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 SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) 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:50090-6164-0 10 in 1 BOTTLE; Type 0: Not a Combination Product 10/12/2022 2 NDC:50090-6164-4 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/12/2022 3 NDC:50090-6164-5 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/12/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075209 02/01/2020 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-6164) , REPACK(50090-6164)