Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions

Description

FDA is informing manufacturers, members of the medical and scientific community, and other interested persons that at this time we do not intend to take action against the marketing of single- and combination-ingredient, acetaminophen-containing, nonprescription (commonly referred to as over-the-counter (OTC)) drug products bearing an allergy warning as described in this guidance (see section III, Discussion and Policy) alerting consumers that the use of acetaminophen may cause severe skin reactions.

Scope & Applicability

• 21CFR331.15§ 331.15 Combination with nonantacid active ingredients.

  (a) An antacid may contain any generally recognized as safe and effective nonantacid laxative ingredient to correct for constipation caused by the antacid. No labeling claim of the laxative effect may be used for such a product.Read full regulation →

• 21CFR341.40§ 341.40 Permitted combinations of active ingredients.

  The following combinations are permitted provided each active ingredient is present within the dosage limits established in parts 341 , 343 , and 356 of this chapter and the product is labeled in accordance with §§ 341.70 or 341.85 :Read full regulation →

• Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products for Over-the-Counter Human Use (Small Entity Compliance Guide): Guidance for Industry (Status: Final)