Prilosec Otc Tablet, Delayed Release
FDA Label NDC 84126-301

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Prilosec Otc (NDC 84126-301). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, use, warnings, otc - do not use, ask a doctor before use if you have:, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Safety Feature - Do not use if tablet blister unit is open or torn.

Dist. by Procter & Gamble,
Cincinnati, OH 45202

Purpose

Acid reducer

Use

  • treats frequent heartburn (occurs 2 or more days a week)
  • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

* Please review the disclaimer below.