HUMCO STRONG IODINE- iodine and potassium iodide liquid

Humco Strong Iodine by

Drug Labeling and Warnings

Humco Strong Iodine by is a Prescription medication manufactured, distributed, or labeled by Humco Holding Group, Inc., Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Strong Iodine Solution

Active Ingredient

Iodine 5 %

Potassium iodide 10%

Purpose

Iodine supplement

CAUTION TO PHYSICIAN:

Read the following indications, Side Effects, Precautions and Caotraindications as a reminder in evaluating each case for supplemental iodine.

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:

Iodine should not be given to cases of active Tuberculosis, or those known to be sensitive to iodine, and discontinued in cases later developing a sensitivity to the iodine therapy.

WARNINGS

WARNING: Large doseage may cause iodine poisoning.

SPL UNCLASSIFIED SECTION

FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION.

Keep out of the reach of children.

In case of acciedntal overose, seek professional assistance or contact a Poison Control Center immediately.

Warnings

VESICATION AND DESQUAMATION MAY OCCUR IF ALLOWED TO POOL IN CONTACT WITH THE SKIN. EXCESS IODINE SHOULD BE REMOVED WITH ALCOHOL TO PREVENT "IODINE BURNS."

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:

If in eyes: Immediately flush eyes with plenty of water for 15 minutes.

If on skin: Immediately wash skin with plenty of water for 15 minutes.

If swallowed: CALL A PHYSICIAN.  Do not induce vomiting. If conscious, give water, milk, or milk of magnesia.

Directions:

DOSAGE: USUAL DOSE; 4-1/2 minimis 3 times daily. Dilute with water or juie.

USUSAL DOSE RANGE: 1-1/2 to 15 minims daily.

Other infomation

CAUTION: THIS CONTAINER IS NOT "CHILD PROOF" AND MUST NOT BE SOLD FOR USE IN OR AROUND THE HOME.

Inactive ingredient

Purified water

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 - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	manufacture(0395-2775) , analysis(0395-2775) , pack(0395-2775) , label(0395-2775)