Label: ALLERGY RELIEF NON DROWSY- loratadine tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 50090-4266-0 - Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 69230-312
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 1, 2021
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
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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
- ALLERGY RELIEF NON DROWSY (LORATADINE) TABLET
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INGREDIENTS AND APPEARANCE
ALLERGY RELIEF NON DROWSY
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-4266(NDC:69230-312) 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 GG296 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-4266-0 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/17/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075209 12/31/2018 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-4266) , REPACK(50090-4266)