How to read a medicine label

A long read

Before we start

This module reads the United States over-the-counter label — the Drug Facts panel the FDA requires. Other countries use their own layout. Canada's is close, but not identical. What travels is the reading order: the active ingredient first, then the dose, then the warnings — and the fact that one active ingredient hides in many products under many brand names.

Sources

FDA, 21 CFR § 201.66 — the Drug Facts panel and its fixed order; § 201.63 pregnancy/breast-feeding warning; § 201.322/326 alcohol warning
FDA, "Don't Overuse Acetaminophen" and Federal Register (2011) — the 4,000 mg adult daily maximum; overdose as a leading cause of acute liver failure
McNeil Consumer Healthcare (2011) — voluntarily lowered its own Extra Strength Tylenol label to 3,000 mg/day; an FDA suggestion, never an FDA requirement
FDA, proposed order to remove oral phenylephrine as an OTC nasal decongestant (2024–25), following the unanimous 2023 advisory-committee vote on efficacy; nasal sprays unaffected
FDA, Generic Drug Facts — generics must match active ingredient, strength and bioequivalence; typically 80–85% cheaper; trademark law forces a different look
FDA Shelf Life Extension Program analysis — about 88% of tested lots retained full potency past the printed date when stored properly; nitroglycerin and most liquids are exceptions

Poison Control (National Capital Poison Center), "Over-the-counter (OTC) drug labels"

Harvard Health — acetaminophen, the liver, and stacked doses

Read end to end and corrected: August 9, 2026. Numbers checked: August 9, 2026.