Label: ALLERVARX- loratadine tablet, orally disintegrating
- NDC Code(s): 57483-950-10
- Packager: Innovus Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 30, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
- Warnings
- Do not use
- 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
- Safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally Disintegrating Tablet, USP is open or torn
- store between 20° to 25°C (68° to 77°F)
- use tablet immediately after opening individual blister
- complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ALLERVARX
loratadine tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57483-950 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) PULLULAN (UNII: 8ZQ0AYU1TT) POLYSORBATE 80 (UNII: 6OZP39ZG8H) MANNITOL (UNII: 3OWL53L36A) Product Characteristics Color white Score no score Shape ROUND Size 12mm Flavor MINT Imprint Code T10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57483-950-10 3 in 1 CARTON 05/30/2022 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA213294 05/30/2022 Labeler - Innovus Pharmaceuticals, Inc. (962507187) Establishment Name Address ID/FEI Business Operations Tenshi Kaizen Pvt Ltd 675478488 manufacture(57483-950) , pack(57483-950) , analysis(57483-950)