Antimonium Iodatum 4 CH • Argentum metallicum 4 CH • Calcarea Fluorica 4 CH. D-Sorbitol, Lactose, Magnesium Stearate.
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In 2004, Canada began regulating natural medicines as a category of products separate from foods or drugs. These products are officially recognized as "Natural Health Products." These products include vitamins, minerals, herbal preparations, homeopathic products, probiotics, fatty acids, amino acids, and other naturally derived supplements.
In order to be marketed in Canada, natural health products must be licensed. In order to be licensed in Canada, manufacturers must submit applications to Health Canada including information about uses, formulation, dosing, safety, and efficacy.
Products can be licensed based on several criteria. Some products are licensed based on historical or traditional uses. For example, if an herbal product has a history of traditional use, then that product may be acceptable for licensure. In this case, no reliable scientific evidence is required for approval.
For products with non-traditional uses, some level of scientific evidence may be required to support claimed uses. However, a high level of evidence is not necessarily required. Acceptable sources of evidence include at least one well-designed, randomized, controlled trial; well-designed, non-randomized trials; cohort and case control studies; or expert opinion reports.
Finished products licensed by Health Canada must be manufactured according to Good Manufacturing Practices (GMPs) as outlined by Health Canada.
This is a homeopathic preparation. Homeopathy is a system of medicine established in the 19th century by a German physician named Samuel Hahnemann. Its basic principles are that "like treats like" and "potentiation through dilution." For example, in homeopathy, diarrhea would be treated with an extreme dilution of a substance that normally causes diarrhea when taken in high doses.
Practitioners of homeopathy believe that more dilute preparations are more potent. Many homeopathic preparations are so diluted that they contain little or no active ingredient. Therefore, most homeopathic products are not expected to have any pharmacological effects, drug interactions, or other harmful effects. Any beneficial effects are controversial and cannot be explained by current scientific methods.
Dilutions of 1 to 10 are designated by an "X." So a 1X dilution = 1:10, 3X=1:1000; 6X=1:1,000,000. Dilutions of 1 to 100 are designated by a "C." So a 1C dilution = 1:100; 3C = 1:1,000,000. Dilutions of 24X or 12C or more contain zero molecules of the original active ingredient.
Homeopathic products are permitted for sale in the US due to legislation passed in 1938 sponsored by a homeopathic physician who was also a Senator. The law still requires that the FDA allow the sale of products listed in the Homeopathic Pharmacopeia of the United States. However, homeopathic preparations are not held to the same safety and effectiveness standards as conventional medicines. For more information, see the Homeopathy monograph.
Below is general information about the effectiveness of the known ingredients contained in the product N Ute Tag. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product N Ute Tag. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY UNSAFE ...when used orally, topically, or intravenously. Total daily silver intake should not exceed 14 mcg/kg daily, or 980 mcg daily for a 70 kg person. Combining colloidal silver supplements with regular dietary intake of silver would likely result in exceeding this amount of silver. Silver accumulates in the body and can lead to an irreversible bluish skin discoloration known as argyria. Neurological deficits and diffuse silver deposition in visceral organs can also occur (5525,8148,8149,10647,10648,12092,92137,92138,92139,102575). In 1999, the US Food and Drug Administration (FDA) ruled that there is no evidence for the safety or effectiveness of colloidal silver products (14255,92137).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally, topically, or intravenously.
Silver appears to cross the placenta (92140). Epidemiological evidence links increased silver levels to developmental anomalies of the ear, face, and neck (5525). Colloidal silver supplements can also lead to silver accumulation and an irreversible bluish skin discoloration known as argyria. Neurological deficits and diffuse silver deposition in visceral organs can also occur (5525,5526,8148,8149,10647,10648,12092,92137,92138,92139).
LIKELY SAFE ...when used orally and appropriately. Fluoride is safe when used in doses below the tolerable upper intake level (UL) of 10 mg daily of elemental fluoride (7555). ...when used topically and appropriately. Fluoride is safe when used in quantities typically found in toothpastes, mouth rinses, and professionally applied fluoride dental treatments (8950,101102,101105).
CHILDREN: LIKELY SAFE
when used orally and appropriately.
Elemental fluoride is safe when used in doses below the daily tolerable upper intake level (UL) of 0.7 mg for 0-6 months of age, 0.9 mg for 7-12 months of age, 1.3 mg for 1-3 years of age, 2.2 mg for 4-8 years of age, and 10 mg for children 8 years and older (7555). Although infants and children have consumed fluoridated water with apparent safety for many years, some population research suggests that more information is needed to determine a safe level of fluoride exposure in infants and children living in regions with fluoridated water. Population research has found an association between urinary fluoride levels and diagnosis of ADHD with higher inattention scores at age 14 years, but not at age 9 years (103551). Also, there is some concern that reconstitution of infant formula with fluoridated water might result in fluoride intakes above the UL in infants under 6 months of age, which may be linked to negative cognitive effects (103529). The Canadian Dental Association recommends that when infant formulas are used as the main source of nutrition, drinking water that contains natural fluoride above recommended levels should not be used to reconstitute the formula (103545). More research is needed to determine whether these effects are due to fluoride or to confounding factors such as socioeconomic status, use of formula instead of breast-feeding, parental intelligence, choice of IQ tests used in studies, and other factors (103542,103544). ...when used topically and appropriately. Fluoride is safe in quantities typically found in toothpastes, mouth rinses, and professionally applied fluoride dental treatments (8950,9100,94406,107648).
CHILDREN: POSSIBLY UNSAFE
when used orally in high doses, long-term.
Exposure to high doses above the UL for greater than 10 years can cause skeletal fluorosis (7555). To reduce fluoride intake, toothpaste and fluoride rinses should not be routinely swallowed. Recommend limiting the use of toothpaste to a pea-sized amount for children 6 years and younger in case of accidental swallowing (9100). When infant formulas are used as the main source of nutrition, drinking water that contains natural fluoride above recommended levels should not be used to reconstitute the formula (103545).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately.
Elemental fluoride is safe when used in doses below the tolerable upper intake level (UL) of 10 mg daily (7555). Although fluoridated water has been consumed during pregnancy with apparent safety for many years, some population research suggests that more information is needed to determine a safe level of fluoride exposure for those living in regions with fluoridated water. Some emerging population research suggests that increased fluoride intake during pregnancy, from appropriately fluoridated water or fluoridated salt, might be associated with negative cognitive effects in the infant (103543,103547). However, more information is needed to determine if these results are clinically significant at the population level, as well as whether these effects are due to fluoride or to confounding factors such as socioeconomic status, use of formula instead of breast-feeding, parental intelligence, choice of IQ tests used in studies, and other factors (103542,103544,103546,103547,103548,103549,103550). ...when used topically and appropriately. Fluoride is safe in quantities typically found in toothpastes, mouth rinses, and professionally applied fluoride dental treatments (8950).
PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally at doses above the tolerable upper intake level (UL) of 10 mg daily of elemental fluoride for prolonged periods.
Long-term exposure to high doses can cause skeletal fluorosis, but pregnancy or lactation doesn't seem to affect susceptibility to skeletal fluorosis (7555).
Below is general information about the interactions of the known ingredients contained in the product N Ute Tag. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Below is general information about the adverse effects of the known ingredients contained in the product N Ute Tag. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...Orally, topically, or via inhalation, colloidal silver can cause serious adverse effects.
Most Common Adverse Effects:
All routes of administration: An irreversible deposition of silver in the skin and mucous membranes with chronic use or high doses can cause a grey-blue discoloration known as argyria. Colloidal silver has also been associated with vision loss and organ damage.
Dermatologic ...Orally, topically, or via inhalation, long-term use of colloidal silver can lead to an irreversible deposition of silver compounds in the mucous membranes, skin, and nails. This condition, which is known as argyria, has been described in numerous case reports (5525,8148,8149,10647,10648,12092,44474,44493,44498,44501)(44514,44523,44528,44538,44540,44547,44593,44638,44649,44726)(44788,44825,44815,92137,92138,92139,96760,102571,102572,102573)(102575,112289). Argyria is characterized by a blueish-gray discoloration which occurs when the silver compounds from colloidal silver are reduced to elemental silver (44474,92139). Since sunlight catalyzes the reduction of silver compounds to elemental silver, sun exposed regions are usually most affected (92138,92139). The blueish-gray discoloration also occurs because colloidal silver can stimulate melanin production in skin (92139). Argyria typically first appears in the gingiva with a slate-blue silver line (5525). It can also occur in the fingernails, where it may be an early sign of silver ingestion and is also known as azure lunula (8149,10648,112289). Argyria usually occurs after ingestion of 4-5 grams of colloidal silver (92138). Although the blueish-gray discoloration associated with argyria is permanent, laser treatment may be used to lighten the skin (92139).
Hematologic ...Intravenously, severe anemia and leukopenia with elevated serum ferritin have been reported in various patients given colloidal silver. In one case, a 30‐year‐old female experienced severe anemia after receiving 48 infusions with a specific colloidal silver marketed for oral use (Argentyn 23). The infusions provided silver 883 mg and were administered over 3 months. The patient was treated for anemia with oral copper, as well as four apheresis treatments. Similar symptoms occurred in other females who were treated with oral copper and repeated blood transfusions. The anemia associated with colloidal silver is related to a decline in serum levels of copper, which is needed for the production of hemoglobin (102570).
Hepatic ...Orally and intravenously, hepatotoxicity has been reported. A 64-year-old male experienced cholelithiasis with acute encephalopathy after repeated oral dosing with colloidal silver providing 2838 ppm of silver over 4 hours (102572). Intravenously, elevated liver enzymes, up to 150 times normal, have been reported in a 30‐year‐old female who received 48 infusions with a specific colloidal silver marketed for oral use (Argentyn 23) providing silver 883 mg over 3 months (102570).
Neurologic/CNS ...At least two cases of myoclonic seizures have been reported after the use of homemade colloidal silver preparations (44485,44649). In one case, myoclonic status epilepticus and coma occurred secondary to consumption of a homemade colloidal silver drink (Schaffer's Health Center Ltd., Unity). The patient had consumed at least one ounce daily for 4 months. The seizures did not respond to benzodiazepines, valproate, phenytoin, phenobarbital, or propofol. The patient required mechanical ventilation and remained in a coma in the intensive care unit for 50 days (44485). In another case, myoclonic seizures and aspiration pneumonia occurred in a 75-year-old male who ingested "several spoons" of homemade colloidal silver up to 4 times daily whenever he "felt a cold coming on" for 4 years. The seizures were treated with clonazepam, and after being hospitalized for 2 months, he was discharged to a nursing home (44649). A more recent case report describes a 70-year-old male hospitalized after exhibiting expressive aphasia, focal seizure followed by generalized seizure, hypertension, encephalopathy, and an abnormal electroencephalogram. The patient had been self-medicating with colloidal silver 1 ounce daily, and blood tests revealed silver levels nearly 16 times that of normal. Extensive tests could not identify any other probable cause other than the silver use. The patient recovered and was discharged on levetiracetam, which was well tolerated at 2 months follow-up. The colloidal silver was a home-made electrolysis preparation using direct current, silver anodes, and steam distilled water (112290).
Ocular/Otic ...Chronic ingestion or inhalation of colloidal silver may cause silver deposition in the eye. This condition is known as ocular argyrosis, which is characterized by a blueish-gray discoloration of the eye (44514,102571). In one case report, chronic use of oral colloidal silver over 9 years resulted in a 2-week history of loss of vision in one eye (102571). Topically, use of eye drops containing colloidal silver can also cause this condition (44821). In one report, a case of ocular argyrosis reportedly occurred in a patient with long-standing herpetic keratitis after only one treatment with eye drops consisting of a 1% solution of colloidal silver (44822).
Oncologic ...Orally, chronic intake of colloidal silver over a 10-year period may have caused bone marrow damage, possibly contributing to the diagnosis of acute myeloid leukemia in a 72-year-old male. The patient died of respiratory failure related to recurrent pneumonia (102574).
Renal ...Orally, glomerulonephritis has been reported in a 47-year-old female who took colloidal silver to treat her T-cell lymphoma. She was treated with hemodialysis, intravenous methylprednisolone, and intravenous cyclophosphamide (102575).
General
...Orally, fluoride seems to be well tolerated.
Most Common Adverse Effects:
Orally: Gastrointestinal symptoms.
Topically: Stained teeth.
Serious Adverse Effects (Rare):
Orally: Allergic reactions, including atopic dermatitis, exfoliative dermatitis, gastrointestinal allergic reactions, inflamed lips, respiratory allergic reactions, stomatitis, and urticaria.
Cardiovascular ...A meta-analysis shows that exposure to drinking water high in fluoride is associated with increases in both systolic and diastolic blood pressure, and possibly an increased risk of developing hypertension, when compared with exposure to drinking water with low to normal levels. High levels of fluoride were defined as 1.02-4.06 mg/L and low to normal levels were defined as 0.18-0.84 mg/L (107650).
Gastrointestinal
...Orally, fluoride can cause gastrointestinal symptoms (94405).
Enteric-coated and sustained-release dosage forms of sodium phosphate and sodium monofluorophosphate may cause fewer adverse effects than plain sodium fluoride (9127,9129). Adverse effects appear to be dose related. Sodium fluoride at high daily doses of 40-65 mg can cause nausea, vomiting, and GI bleeding (15,9127).
Fluoride can cause enamel fluorosis, a condition in which the ingestion of excessive amounts of fluoride during the development of permanent teeth may cause discoloration and pitting. This is a cosmetic effect only; tooth enamel may be stronger and more resistant to caries with enamel fluorosis (7555). Topically, use of stannous fluoride in toothpaste has caused staining of the teeth (94409).
Immunologic ...Exposure to fluoride can cause allergic reactions including urticaria, exfoliative dermatitis, atopic dermatitis, stomatitis, and gastrointestinal allergic reactions. Respiratory allergic reactions occur rarely (15,94408). A case of dermatitis around the mouth was thought to be related to the high fluoride levels in a specific toothpaste (NeutraFluor 5000 Plus) (94408). In another case report, lip inflammation occurred in reaction to the amine fluoride in a toothpaste product (94404). Lip inflammation and urticaria were also reported in reaction to a specific brand of toothpaste (Crest Pro-Health). However, it is not clear if this reaction occurred in response to the fluoride or tin component of stannous fluoride (94403).
Musculoskeletal ...Orally, sodium fluoride 40-65 mg daily can cause lower extremity pain and stress fractures (15,9127,94405). Fluoride at high doses for prolonged periods, over 10 mg daily for 10 or more years, can cause skeletal fluorosis. Skeletal fluorosis initially presents as joint stiffness and pain, followed by crippling, osteosclerosis, muscle wasting, and neurological defects due to hyper calcification of the vertebra. Crippling skeletal fluorosis is extremely rare in the US (7555).
Neurologic/CNS
...Exposure to high levels of natural fluoride during neurodevelopment in childhood is associated with a decreased IQ score.
This relationship has been shown in numerous population studies comparing areas with water containing high levels of natural fluoride (e.g. up to 11.5 mg/L) with the standard concentrations (0.7-1.2 mg/L) normally found in fluoridated water (94401,103544). The Canadian Dental Association recommends that when infant formulas are used as the main source of nutrition, drinking water that contains natural fluoride above recommended levels should not be used to reconstitute the formula (103545).
There is some concern that levels of fluoride found in optimally fluoridated water sources might also impact neurodevelopment during infancy or childhood. For example, population research in Canada has found a relationship between urinary fluoride levels and diagnosis of ADHD with higher inattention scores at age 14 years, but not at age 9 years. At 14 years, the predicted odds of an ADHD diagnosis was 2.8 times greater than the odds for youth in non-fluoridated regions (103551). In addition, in infants under 6 months of age using formula as the main source of energy, there is some concern that reconstitution of formula with fluoridated water might result in fluoride intakes above the tolerable upper intake level (UL). One observational study in Canada found that for each 0.5-gram increase in fluoride from reconstituted formula, there is an 8.8-point decrement in performance IQ, which measures non-verbal reasoning and visual-motor coordination, at 3-4 years of age. However, there was no association with global intellectual functioning or verbal reasoning (103529).
There is also some concern that levels of fluoride found in optimally fluoridated water sources might impact fetal neurodevelopment. Emerging population research found that increased fluoride intake during pregnancy, from appropriately fluoridated water or fluoridated salt, might be associated with negative cognitive effects. One observational study in Canada found that for each 1 mg/L increase in maternal urinary fluoride, there is a 3.7-point decrement in IQ in children aged 3-4 years, with a greater reduction in non-verbal abilities than verbal abilities. A sub-analysis revealed a decrement of 4.5 points in males, with no decrement in females (103543,103547). Another study found that increased exposure to fluoride during pregnancy is associated with symptoms of inattention in the offspring at age 6-12 years (103550).
The findings of these studies are interesting and support further research. More information is needed to know if these results are clinically significant at the population level (103548,103549,103550). In addition, although effort was made to take confounding factors into consideration, more information is needed to determine whether these neurological effects are related to fluoride exposure during pregnancy or to other factors such as socioeconomic status, use of formula instead of breast-feeding, parental intelligence, choice of IQ tests used in studies, and others. Also, the actual intake of fluoride was not known in most cases (94401,103542,103544,103546,103547,103548,103549,103550).
Other ...Population research in adolescents has found that having plasma fluoride levels of at least 0. 32 micromol/L or consuming water with fluoride levels of at least 0.73 mg/L increases the odds of hyperuricemia by approximately 1.8-fold when compared with the lowest quartiles. In addition, serum uric acid levels are increased by 0.212 mg/dL for each icromole/L increase in plasma fluoride levels (107645).