VITA AID · 99-39 · CANADA

Product code, Product and FDA notes

62 K B Y 08 Loperamide Hydrochloride (Anti-Peristaltic, Anti-Diarrheal), Human - Non/Rx Combination Ingredient, NEC Date Published: 09/23/2026 Desc: Baby and Mom PB15DF Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) [21 U.S.C. § 343(q)] of the Federal Food, Drug, and Cosmetic Act, specifically under subsection 403(q)(5)(F), because the nutrition information on the product labeling fails to comply with the presentation and formatting requirements of 21 CFR 101.36. The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 343(a)(1)] because its labeling and product name are false or misleading in any particular. Specifically, the labeling does not comply with 21 CFR 101.18. The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label does not bear an appropriate statement of net quantity of contents in accordance with 21 CFR 101.7. Specifically, the product label declares the net weight with the qualifying term "Approx." ("Net Wt. Approx. 3.17 oz (90 g)") in a manner that is not consistent with 21 CFR 101.7 (or 21 CFR 101.105) because it qualifies the net quantity statement and fails to provide an accurate statement of the quantity of contents.