Search by Drug Name or NDC
NDC 00395-2775-16 Humco Strong Iodine 50; 100 mg/mL; mg/mL Details
Humco Strong Iodine 50; 100 mg/mL; mg/mL
Humco Strong Iodine is a ORAL LIQUID in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Humco Holding Group, Inc.. The primary component is IODINE; POTASSIUM IODIDE.
Product Information
| NDC | 00395-2775 |
|---|---|
| Product ID | 0395-2775_da6c5009-ea01-25c6-e053-2995a90ab727 |
| Associated GPIs | 79350032002020 |
| GCN Sequence Number | 001674 |
| GCN Sequence Number Description | potassium iodide/iodine SOLUTION 5 % ORAL |
| HIC3 | C3H |
| HIC3 Description | IODINE CONTAINING AGENTS |
| GCN | 61140 |
| HICL Sequence Number | 000747 |
| HICL Sequence Number Description | POTASSIUM IODIDE/IODINE |
| Brand/Generic | Generic |
| Proprietary Name | Humco Strong Iodine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Iodine and potassium iodide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 50; 100 |
| Active Ingredient Units | mg/mL; mg/mL |
| Substance Name | IODINE; POTASSIUM IODIDE |
| Labeler Name | Humco Holding Group, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 00395-2775-16 (00395277516)
| NDC Package Code | 0395-2775-16 |
|---|---|
| Billing NDC | 00395277516 |
| Package | 473 mL in 1 BOTTLE, PLASTIC (0395-2775-16) |
| Marketing Start Date | 2017-11-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL cf5b0102-4f76-4f9e-907a-bf9425890aea Details
CAUTION TO PHYSICIAN:
Use
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.
CONTRAINDICATIONS:
Keep out of the reach of children.
Warnings
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:
Directions:
Other infomation
INGREDIENTS AND APPEARANCE
| HUMCO STRONG IODINE
iodine and potassium iodide liquid |
|||||||||||||||
|
|||||||||||||||
|
|||||||||||||||
|
|||||||||||||||
|
|||||||||||||||
|
|||||||||||||||
| 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) | |