Label: HUMCO STRONG IODINE- iodine and potassium iodide liquid
- NDC Code(s): 0395-2775-16
- Packager: Humco Holding Group, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated March 17, 2022
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- CAUTION TO PHYSICIAN:
Source of Iodne
INDICTAIONS: This product has several uses where iodine is indicated. This product may be used in the treatment of hyperthyroidism in the immediate preoperative period in preparation for thyroidectomy. It may be used alone, but more frequently is used after the hyperthyroidism is controlled by an antithyroid drug. It is given during the 10 days immediately prior to the operation. Optimal control of Hyperthyroidism is achieved if antithyroid drugs are first given alone. This product is also used in thyrotoxicosis crisis in conjunction with supportive measures to control fever and adequate fluid intake.
- SPL UNCLASSIFIED SECTION
- Keep out of the reach of children.
SIDE EFFECTS AND PRECAUTIONS:
Iodine therapy does not completly control the manifestations of hyperthyroidism in that after a variable period of time, the beneficial effects wear off. With continue administration of iodine, the hyperthyroidism may return in its initial intensity or may become even more severe than it was at first. Measurements of the protein bound iodine or of the uptake of radioiodine are rendered useless if iodine is given. Average dosage of iodine may cause skin rash. Iodine readily crosses the placental barrier and may affect the fetus. Prolonged therapy may cause iodism. The ingestion of large quantities of iodine may casue abdominal pain, nausea, vomiting and diarhea.
- FIRST AID INSTRUCTIONS FOR ACCIDENTAL EXPOSURE:
- Other infomation
- Inactive ingredient
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
HUMCO STRONG IODINE
iodine and potassium iodide liquid
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0395-2775 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 50 mg in 1 mL POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0395-2775-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/14/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2008 Labeler - Humco Holding Group, Inc. (825672884) Registrant - Pharma Nobis, LLC (118564114) Establishment Name Address ID/FEI Business Operations Pharma Nobis, LLC 118564114 manufacture(0395-2775) , analysis(0395-2775) , pack(0395-2775) , label(0395-2775)