Label: LORATADINE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 50090-3620-0, 50090-3620-1, 50090-3620-3, 50090-3620-4, view more50090-3620-5, 50090-3620-6 - Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 16714-482
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 29, 2019
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?
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HOW SUPPLIED
Product: 50090-3620
NDC: 50090-3620-0 10 TABLET in a BOTTLE
NDC: 50090-3620-3 15 TABLET in a BOTTLE, PLASTIC
NDC: 50090-3620-4 30 TABLET in a BOTTLE, PLASTIC
NDC: 50090-3620-5 90 TABLET in a BOTTLE, PLASTIC
NDC: 50090-3620-1 20 TABLET in a BOTTLE, PLASTIC
NDC: 50090-3620-6 7 TABLET in a BOTTLE, PLASTIC
- Loratadine
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INGREDIENTS AND APPEARANCE
LORATADINE
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-3620(NDC:16714-482) 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 POTATO (UNII: 5856J3G2A2) Product Characteristics Color WHITE (white to off 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:50090-3620-0 10 in 1 BOTTLE; Type 0: Not a Combination Product 11/15/2018 2 NDC:50090-3620-3 15 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2016 3 NDC:50090-3620-4 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2016 4 NDC:50090-3620-5 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2016 5 NDC:50090-3620-1 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2016 6 NDC:50090-3620-6 7 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075209 02/01/2016 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-3620) , REPACK(50090-3620)