Label: LORATADINE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 68210-4126-1 - Packager: Spirit Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 29, 2022
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- Active ingredient
- Purpose
- Uses
- Warnings
- Ask a doctor before use if
- When usung this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LORATADINE
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-4126 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) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE (UNII: FZ989GH94E) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white (White to off white) Score no score Shape ROUND Size 6mm Flavor Imprint Code P;10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-4126-1 365 in 1 PACKAGE; Type 0: Not a Combination Product 04/07/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214684 04/07/2021 Labeler - Spirit Pharmaceuticals LLC (179621011)