§332.15. Combination with non-antiflatulent active ingredients. — Inbound Citations
21 C.F.R. § 332.15
Statutory Authority
Cited by 1 regulation in release Current.
Citations to 21 C.F.R. § 332.15 as a whole
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(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.”