All relevant safety information has been submitted and approved under COLD-FX®(Natural Product Number 80002849) and COLD-FX® EXTRA (Natural Product Number 80015586). Included in each submission is safety data from clinical trials, pharmacology & toxicology studies, interaction studies, marketing experience and summarization of adverse reactions.
Laboratory studies have demonstrated there were no effected of COLD-FX® on the tested major drug-metabolizing enzymes and drug transporters in the liver, suggesting low possibilities of drug-drug interactions.
Most importantly, known and defined side effects were not found to be associated with the recommended daily intake of COLD-FX® in clinical trials with healthy adults and seniors, and there were no known interactions of COLD-FX® with several concomitant medications. In clinical studies with COLD-FX®, individuals taking immunosuppressive drugs or corticosteroids, having serious medical conditions, or known to be allergic to ginseng products were excluded based on established safety and cautions for all ginseng species.
To be safe, individuals with serious medical conditions or taking prescription medications should always consult a healthcare practitioner before taking COLD-FX®.
Warnings and precautions
Individuals requiring anti-coagulant therapy such as warfarin should avoid use of COLD-FX®
Do not use if pregnant or breastfeeding
Not recommended for individuals with impaired liver or renal function
Individuals with known allergies to ginseng should avoid use of COLD-FX®
Do not exceed the recommended daily dose
Consult a health care practitioner prior to use if you have diabetes.
High K, Case D, Hurd D et al. A randomized, controlled trial of panax quinquefolius extract (CVT-E002) to reduce respiratory infection in patients with chronic lymphocytic leukemia. J Support Oncol 2012;10:195-201.
McElhaney JE, Goel V, Toane B et al. Efficacy of COLD-FX in the prevention of respiratory symptoms in community-dwelling adults: a randomized, double-blinded, placebo controlled trial. J Altern Complement Med 2006;12(2):153-7.
McElhaney JE, Gravenstein S, Cole SK et al. A placebo-controlled trial of a proprietary extract of North American ginseng (CVT-E002) to prevent acute respiratory illness in institutionalized older adults. J Am Geriatr Soc 2004;52:13-9.
McElhaney JE, Simor AE, McNeil S et al. Efficacy and safety of CVT-E002, a proprietary extract of panax quinquefolius in the prevention of respiratory infections in influenza-vaccinated community-dwelling adults: a multicenter, randomized, double-blind and placebo-controlled trial. Influenza Res Treat 2011;2011:1-8.
Predy GN, Goel V, Lovlin RE et al. Efficacy of an extract of North American ginseng containing poly-furanosyl-pyranosyl-saccharides for preventing upper respiratory tract infections: a randomized controlled trial. Can Med Assoc J 2005;173(9): 1043-8.
Ueng Y, Chen C. Effects of CVT-E002, a proprietary extract from North American ginseng (Panax Quinquefolium) on drug-metabolizing enzymes. J Chin Med 2002;13:89-96.
Vohra S, Johnston BC, Laycock KL et al. Safety and tolerability of North American ginseng extract in the treatment of pediatric upper respiratory tract infection: a phase II randomized, controlled trial of 2 dosing schedules. Pediatrics 2008;122:e402-10.