This specific issue may not be clinically significant, but I wanted to inquire if others have developed standards for labeling OTC vitamins with multiple ingredients. We recently encountered a bottle of Vitamin D 10 mcg that had both Vitamin D and calcium listed under the "Supplement Facts" portion of the label. Percentage of RDI was 50% for Vitamin D, and 2% for calcium (25 mg as calcium carbonate). All would have been well, except the front of the label contained Vitamin D with no mention of calcium. Our wholesaler's website also had the product listed as Vitamin D, with no mention of calcium.

FDA labeling guidelines require manufactures to include amount per serving as percentage of RDI for certain vitamins and minerals, like Vitamin A, C, calcium, etc. under "Supplement Facts" if they exceed 2% of RDI (see 21 CFR 101.9(c)(8)(iv)). The question we faced when unit dosing this product was if we should label it as purely as Vitamin D 10 mcg, or Vitamin D 10 mcg + calcium carbonate 25 mg. I would appreciate hearing your thoughts on this question. Thank you!