1. Ingredients: What is COLD-FX Extra Strength?
COLD-FX Extra Strength is a highly purified ChemBioPrint product derived from the roots of North American ginseng (Panax quinquefolius). Each capsule contains 300 mg of, CVT-E002, a unique extract of polysaccharides that has been shown in laboratory and clinical studies to boost the immune system. Through Afexa Life Sciences' proprietary process, COLD-FX Extra Strength undergoes vigorous testing to ensure that every batch has consistent chemical identity and biological activity.
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2. What is ChemBioPrint (CBP)?
ChemBioPrint stands for Chemical Biological FingerPrinting, proprietary standardization technology used to ensure the quality of all ChemBioPrint products. In the case of COLD-FX Extra Strength, Chemical FingerPrinting identifies a "print" of the active chemical components that boost the immune system. Biological FingerPrinting identifies the effect of the extract on the immune system through a series of laboratory evaluations. As a result of Afexa Life Sciences' proprietary technology, COLD-FX Extra Strength undergoes vigorous testing to ensure that every batch has consistent chemical identity and biological activity.
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3. How is COLD-FX Extra Strength different from other ginseng products?
Most ginseng products on the market are Asian ginseng (Panax ginseng). COLD-FX Extra Strength is a highly purified extract derived from North American ginseng (Panax quinquefolius) which has a very different chemical and biological profile than Asian ginseng. Because COLD-FX Extra Strength is comprised of specific active viral-targeted, immune-enhancing molecules, polysaccharides, it doesn't exhibit the other effects typically associated with ginseng products such as enhanced vitality, mental alertness and mood improvements. In addition, although COLD-FX Extra Strength is an extract of North American ginseng, its highly purified and precise chemical composition makes comparison with "ginseng" in general, inappropriate. Comparing COLD-FX Extra Strength with raw ginseng roots is like comparing acetylsalicylic acid (the active ingredient in Aspirin) with willow tree bark (the source material of acetylsalicylic acid).
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4. What is COLD-FX Extra Strength intended for?
COLD-FX Extra Strength is for boosting the immune system at the first sign of cold or flu symptoms.
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5. How does it work?
A number of studies, including both experimental and clinical, have shown that the active ingredient of COLD-FX Extra Strength works by boosting the immune system. These effects were found on both the innate and the acquired immune responses and both cell-mediated and humoral (antibody)-mediated immunity.
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6. What evidence do you have to support its efficacy and safety?
Unpublished and published pre-clinical and clinical studies support COLD-FX Extra Strength. These studies have shown COLD-FX Extra Strength to be safe and effective when taken at the first sign of symptoms.
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7. What dosage of COLD-FX Extra Strength should I take?
The following three day dosing regimen has been shown effective at the first sign of cold or flu symptoms. Day 1: take 3 capsules 2 times during the day (total = 6 capsules); Day 2: take 2 capsules 2 times during the day (total = 4 capsules); Day 3: take 1 capsule 2 times during the day (total = 2 capsules).
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8. What is the difference between COLD-FX Extra Strength and COLD-FX?
COLD-FX is to be used daily whereas COLD-FX Extra Strength is a higher dosage intended to be used short-term at the first sign of cold or flu symptoms.
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9. What is the difference between COLD-FX Extra Strength and the acute dosing regimen previously marketed?
Consumers have been seeking a convenient, higher potency per capsule of COLD-FX, to be taken at the first sign of cold or flu symptoms. We have therefore decided to increase the amount of active ingredient per capsule from 200 mg to 300 mg and introduce it to the market place as COLD-FX Extra Strength. It’s a new three day dosing regimen.
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10. Are there any side effects associated with COLD-FX Extra Strength?
No side effects are observed in laboratory studies when given at 500 times higher than the recommended dose at 1 time and 25 times higher than the recommended dose for 30 days. In clinical studies, side effects have also not been associated with the recommended dosing regimen. Although there are no known interactions with herbs, drugs or medical conditions, individuals with serious medical conditions or taking medications should consult a health care practitioner before taking COLD-FX Extra Strength.
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11. Will COLD-FX Extra Strength overstimulate my immune system?
Laboratory studies have indicated that the active ingredient of COLD-FX Extra Strength does not overstimulate the immune system, but rather induces more moderate changes which reflect healthy levels of immune system components such as cytokines and Natural Killer (NK) cells.
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12. What about interactions with other drugs such as NSAIDs, antibiotics, lipid-lowering medications, oral contraceptives, blood pressure medications, antidepressants, beta blockers and synthroid?
There are no known interactions of COLD-FX Extra Strength with other medications. Laboratory studies have demonstrated no effect of its active ingredient on the major drug-metabolizing enzymes of the liver. Additionally, the polysaccharides that it is comprised of, are very large molecules. This means they are unlikely to enter the bloodstream and instead exert immune-stimulating effects in the gastrointestinal tract, although this remains to be confirmed in scientific studies. Thus, COLD-FX Extra Strength is thought to exhibit a low likelihood of interaction with other drugs. However, since specific clinical trials have not been conducted to investigate interactions with other medications consult a health care practitioner before using COLD-FX Extra Strength.
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13. I have an autoimmune disorder. Would it be safe for me to take COLD-FX Extra Strength ?
COLD-FX Extra Strength has been demonstrated safe and effective in healthy individuals. Clinical trials have not been conducted specifically in populations with autoimmune diseases. For those with an autoimmune disorder, we recommend consulting a health care practitioner before taking COLD-FX Extra Strength. Our laboratory studies suggest that the active ingredient of COLD-FX Extra Strength is unlikely to interact with other medications, including drugs used to treat autoimmune conditions, but to be safe, please speak to a health care practitioner if you are taking these medications before consuming COLD-FX Extra Strength .
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14. I have diabetes. Would it be safe for me to take COLD-FX Extra Strength?
COLD-FX Extra Strength has been demonstrated safe and effective in healthy individuals. Clinical trials have not been conducted specifically in diabetic populations. To ensure that COLD-FX Extra Strength is safe to consume for individuals with diabetes, we recommend consulting a health care practitioner and monitoring of general health and glucose levels when taking COLD-FX Extra Strength. Our laboratory studies suggest that the active ingredient of COLD-FX Extra Strength is unlikely to interact with other medications, including anti-diabetic drugs, but to be safe, please speak to a health care practitioner if you are taking these medications before consuming COLD-FX Extra Strength.
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15. I have high blood pressure. Would it be safe for me to take COLD-FX Extra Strength?
COLD-FX Extra Strength has been demonstrated safe and effective in healthy individuals. Clinical trials have not been conducted specifically in populations with high blood pressure. To ensure that COLD-FX Extra Strength is safe to consume for individuals with high blood pressure, we recommend consulting a health care practitioner and monitoring of general health and blood pressure when taking COLD-FX Extra Strength. Our laboratory studies suggest that the active ingredient of COLD-FX Extra Strength is unlikely to interact with other medications, including antihypertensive drugs, but to be safe, please speak to a health care practitioner if you are taking these medications before consuming COLD-FX Extra Strength.
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16. I am on blood thinners and I have been advised not to take ginseng products. Would it be safe for me to take COLD-FX Extra Strength?
High doses of some forms of ginseng which are high in ginsenosides have been shown to affect the metabolism and effect of blood thinners such as warfarin. Although COLD-FX Extra Strength is composed of molecules, polysaccharides, which are not thought to cause drug interactions, and laboratory and clinical studies have indicated that the likelihood of drug interaction with COLD-FX Extra Strength is greatly reduced, to be safe, individuals taking blood thinners thinners should avoid the use of COLD-FX.
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17. Someone mentioned to me that taking COLD-FX Extra Strength might be dangerous for women who have or are at risk for developing cancer and that it "feeds" hormonal cancers. Is this correct?
No, this is not correct. COLD-FX Extra Strength has been clinically demonstrated to be a safe and effective product. There is no evidence suggesting that COLD-FX Extra Strength is unsafe for patients with cancer, or specifically, hormone-related cancers. The active ingredient of COLD-FX Extra Strength has not demonstrated any carcinogenic effects in toxicity studies in any of the clinical trials or through the extensive usage by the general population.
This false impression may relate to some un-confirmed laboratory studies suggesting that crude ginseng containing chemicals known as ginsenosides may have estrogen-related effects. During the manufacturing process of COLD-FX Extra Strength, these ginsenosides are removed so that the final product is comprised of a proven safe ingredient: polysaccharides (specifically, poly-furanosyl-pyranosyl-saccharides).
There is no clinical evidence to suggest that ginseng in general is unsafe for women who have or are at risk for developing hormone-related cancers. In fact, a recent study published in the American Journal of Epidemiology, February 16, 2006 (Cui Y et al, 163(7):645) demonstrated that regular users of ginseng had improved survival and quality of life in breast cancer patients. A well-controlled Mayo Clinic study sponsored by the National Cancer Institute of the U.S. NIH, further investigated the potential benefits of American ginseng in cancer patients, including women. On June 3, 2007, the results of this rigorous pilot study were presented. Researchers found that a form of American ginseng provides greater improvements in fatigue and vitality in patients who received the highest doses tested, compared to lower doses or no treatment. The treatment also appeared to be safe and well tolerated (no statistically significant differences in various safety parameters between each of the study groups). The active ingredient of COLD-FX Extra Strength has also demonstrated anti-cancer effects through immune enhancement in pre-clinical laboratory studies of a leukemia model.
Although there is no evidence to suggest COLD-FX Extra Strength is un-safe for women who have or are at risk for developing hormone-related cancers, it is recommend that individuals with any serious medical condition consult with their health care practitioner prior to taking COLD-FX Extra Strength.
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18. Can I take COLD-FX Extra Strength if I am pregnant or nursing?
Clinical studies have not been conducted on the use of COLD-FX Extra Strength during pregnancy or nursing. Therefore do not use product if pregnant or nursing.
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19. Is COLD-FX Extra Strength recommended for children under the age of 12?
Studies have not been conducted to assess the efficacy or safety of COLD-FX Extra Strength among children under the age of 12 and therefore we do not recommend the use of this product for children in this age group.
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