Label: LORATADINE tablet
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NDC Code(s):
58602-702-04,
58602-702-05,
58602-702-09,
58602-702-15, view more58602-702-17, 58602-702-19, 58602-702-21, 58602-702-23, 58602-702-29, 58602-702-32, 58602-702-38, 58602-702-39, 58602-702-40, 58602-702-44, 58602-702-54, 58602-702-60, 58602-702-67, 58602-702-81, 58602-702-83, 58602-702-84
- Packager: Aurohealth LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated August 13, 2020
If you are a healthcare professional or from the pharmaceutical industry 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 - 10 mg (45 Tablets Bottle)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (45 Tablets)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (30 Tablets)
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INGREDIENTS AND APPEARANCE
LORATADINE
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-702 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) STARCH, CORN (UNII: O8232NY3SJ) 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:58602-702-17 1 in 1 CARTON 04/16/2018 1 45 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:58602-702-15 1 in 1 CARTON 04/16/2018 2 60 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:58602-702-19 1 in 1 CARTON 04/16/2018 3 90 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:58602-702-81 1 in 1 CARTON 04/16/2018 4 108 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:58602-702-32 1 in 1 CARTON 04/16/2018 5 180 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:58602-702-60 1 in 1 CARTON 04/16/2018 6 5 in 1 BLISTER PACK; Type 0: Not a Combination Product 7 NDC:58602-702-83 1 in 1 CARTON 04/16/2018 7 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 8 NDC:58602-702-67 2 in 1 CARTON 04/16/2018 8 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 9 NDC:58602-702-84 3 in 1 CARTON 04/16/2018 9 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 10 NDC:58602-702-05 5 in 1 CARTON 04/16/2018 10 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 11 NDC:58602-702-09 1 in 1 CARTON 05/03/2019 11 30 in 1 BOTTLE; Type 0: Not a Combination Product 12 NDC:58602-702-38 1 in 1 CARTON 05/03/2019 12 300 in 1 BOTTLE; Type 0: Not a Combination Product 13 NDC:58602-702-39 1 in 1 CARTON 05/03/2019 13 365 in 1 BOTTLE; Type 0: Not a Combination Product 14 NDC:58602-702-44 1 in 1 CARTON 07/26/2019 14 400 in 1 BOTTLE; Type 0: Not a Combination Product 15 NDC:58602-702-54 1 in 1 CARTON 10/04/2019 15 70 in 1 BOTTLE; Type 0: Not a Combination Product 16 NDC:58602-702-23 1 in 1 CARTON 10/04/2019 16 120 in 1 BOTTLE; Type 0: Not a Combination Product 17 NDC:58602-702-40 1 in 1 CARTON 11/28/2019 17 500 in 1 BOTTLE; Type 0: Not a Combination Product 18 NDC:58602-702-21 1 in 1 CARTON 12/23/2019 18 100 in 1 BOTTLE; Type 0: Not a Combination Product 19 NDC:58602-702-04 10 in 1 CARTON 02/10/2020 19 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 20 NDC:58602-702-29 1 in 1 CARTON 08/13/2020 20 150 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208314 04/16/2018 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(58602-702) , MANUFACTURE(58602-702)