Label: LORATADINE tablet
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NDC Code(s):
68788-8628-0,
68788-8628-1,
68788-8628-3,
68788-8628-5, view more68788-8628-9
- Packager: Preferred Pharmaceuticals Inc.
- This is a repackaged label.
- Source NDC Code(s): 68001-438
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 11, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each tablet)
- Purpose
- Uses
- Warnings
- Ask a doctor before use if you have
- When using 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?
- PACKAGE LABEL- PRINCIPAL DISPLAY PANEL - 10mg
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INGREDIENTS AND APPEARANCE
LORATADINE
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-8628(NDC:68001-438) 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 MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) 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 39;L Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-8628-0 10 in 1 BOTTLE; Type 0: Not a Combination Product 04/11/2024 2 NDC:68788-8628-1 14 in 1 BOTTLE; Type 0: Not a Combination Product 04/11/2024 3 NDC:68788-8628-5 15 in 1 BOTTLE; Type 0: Not a Combination Product 04/11/2024 4 NDC:68788-8628-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/11/2024 5 NDC:68788-8628-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/11/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208314 04/11/2024 Labeler - Preferred Pharmaceuticals Inc. (791119022) Registrant - Preferred Pharmaceuticals Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals Inc. 791119022 REPACK(68788-8628)