Dosage and Duration of Administration
Each capsule of COLD-fX® contains 200 mg of dried, powdered aqueous extract (CVT-E002), standardized to between 80% and 90% poly-furanosyl-pyranosyl-saccharides.
Daily dose in clinical trials for prevention of respiratory tract infections: In a clinical trial with adults aged 65 and over, the dosage was 400 mg once daily for 4 months.14 The same dose was used in a prevention trial (also 4 months in duration) with adults aged 18–65 years.16 A third clinical trial with adults aged 60 years and older employed a dose of 200 mg 2 times daily (total 400 mg/day) for 8 and 12 weeks.15
Manufacturer dose recommendations/precautions: For adults and children 12 years and over the recommended dosage is 1 (200 mg) capsule 2 times daily for chronic use. Although specific clinical studies were not performed in children aged 12-17 years, this population is included based on a Drug Identification Number (DIN) that the Therapeutic Products Directorate (drug division) of Health Canada issued to COLD-fX (prior to the new Canadian Natural Health Product regulations in 2004). (See the Regulatory Status section below.) For acute use, the recommended dosage is 3 capsules (600 mg) 3 times on the 1st day, 2 capsules (400 mg) 3 times on the 2nd day, and 1 capsule (200 mg) 3 times on the 3rd day. The recommended dosage for continued use is 1-2 capsules per day until the patient feels better. The product should be taken on an empty stomach. Individuals with serious health conditions (e.g., autoimmune disorders, liver or kidney disease) or taking other medications as well as pregnant or lactating females should consult a health care professional before taking COLD-fX®. (See the Pregnancy and Lactation section below.) As COLD-fX® is a derivative of North American ginseng, it is not recommended for individuals allergic to ginseng.
[Note: “Chronic use” implies use for prevention of ARI, suggested by studies of up to 16 weeks. The acute recommended dose applies to use at the onset of symptoms associated with the common cold or influenza. The previously approved Canadian DIN also included the recommended use of “relief of cough due to cold” with acute daily treatment of 2 capsules 3 times per day.]