§335.50. Labeling of antidiarrheal drug products. — Inbound Citations

(2) The labeling shall be printed in accordance with the requirements of § 201.66(d) of this chapter except that any requirements related to § 201.66(c)(3) of this chapter and the bullet in the warning in § 335.50(c)(1)(i) may be omitted.

(i) The words “Contains salicylate.” may be omitted from the warning in § 335.50(c)(2)(i)(B).

(ii) The subheading “When using this product” in § 335.50(c)(2)(iv) may be omitted.

The active ingredient of the product consists of any one of the following when used within the dosage limits established for each ingredient in § 335.50(d):

(iii) The words “continue to” may be omitted from the directions in § 335.50(d)(3).