§332.10. Antiflatulent active ingredients. — Inbound Citations

(f) The labeling for antacid drug products containing the active ingredients identified in § 331.11(a), (b), and (d) through (m); permitted combinations of these ingredients provided for in § 331.10; and any of these ingredients or combinations of these ingredients in combination with simethicone (identified in § 332.10 of this chapter and provided for in § 331.15(c)), are exempt from the requirement in § 330.1(g) of this chapter that the labeling bear the general warning statement “In case of accidental overdose, seek professional assistance or contact a poison control center immediately.” With the exception of sodium bicarbonate powder products identified in § 331.11(k)(1), the labeling must continue to bear the first part of the general warning in § 330.1(g) of this chapter, which states, “Keep this and all drugs out of the reach of children.”

(c) The labeling for antiflatulent drug products containing simethicone identified in § 332.10 and antacid/antiflatulent combination drug products provided for in § 332.15, containing the active ingredients identified in § 331.11(a), (b), and (d) through (m) of this chapter are exempt from the requirement in § 330.1(g) of this chapter that the labeling bear the general warning statement “In case of accidental overdose, seek professional assistance or contact a poison control center immediately.” The labeling must continue to bear the first part of the general warning in § 330.1(g) of this chapter, which states, “Keep this and all drugs out of the reach of children.”