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FDA Warning Letter Explorer
FDA warning letter · Drugs

Procter & Gamble Manufactura S. de R.L. de C.V.

Issued · Posted by FDA

FDA published a close-out letter on Mar 31, 2023. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

the active ingredients included in the labeling do not match the active ingredients included in the electronic listing file in Structured Product Labeling (SPL) format. Specifically, the active ingredients described under the Drug Facts section of the labeling and Principal Display Panel image are acetaminophen, dextromethorphan hbr, doxylamine succinate, and phenylephrine, while the active ingredients included in the electronic listing file in (SPL) are acetaminophen, dextromethorphan hbr, phenylephrine, and guaifenesin. The active ingredient doxylamine is missing from the electronic listing file in (SPL) and instead guaifenesin is included.

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 207.49(a)(4)
  • 21 CFR 207.57(b)(2)
  • 21 CFR 207