No black box warning on record for Acetaminophen

As of the latest FDA labeling reviewed, Acetaminophen (acetaminophen (paracetamol)) does not carry a black box warning. Standard warnings and precautions still apply — see the full Acetaminophen medicine page for the complete safety profile.

Other warnings & precautions

Overdose and Liver Failure: Acetaminophen overdose is the #1 cause of acute liver failure in the US. The toxic metabolite NAPQI accumulates when hepatic glutathione is depleted. Symptoms of overdose may be subtle for 24–72 hours before liver failure manifests. NAC (N-acetylcysteine) is the antidote and must be given early. Do NOT exceed 4g/day (3g/day in elderly or those at risk).
Hidden Sources of Acetaminophen: Acetaminophen is present in >600 OTC and prescription products (NyQuil, Percocet, Vicodin, DayQuil, Excedrin, many cough/cold medications). Patients must read ALL medication labels to avoid inadvertent double-dosing, which is a major cause of unintentional overdose.
Alcohol Warning: OTC label warns that patients who consume 3 or more alcoholic drinks daily should ask a doctor before using acetaminophen. Chronic alcohol use significantly increases hepatotoxicity risk.
Children's Dosing: Pediatric formulations (children's liquid, infant drops) have different concentrations. ALWAYS check the concentration on the label and use the correct dosing device. Do NOT switch between formulations without recalculating the dose.
Severe Skin Reactions: Though rare, acetaminophen has been associated with Stevens-Johnson syndrome and AGEP. Discontinue immediately if skin reactions develop.

Other warnings & precautions

Overdose and Liver Failure: Acetaminophen overdose is the #1 cause of acute liver failure in the US. The toxic metabolite NAPQI accumulates when hepatic glutathione is depleted. Symptoms of overdose may be subtle for 24–72 hours before liver failure manifests. NAC (N-acetylcysteine) is the antidote and must be given early. Do NOT exceed 4g/day (3g/day in elderly or those at risk).

Hidden Sources of Acetaminophen: Acetaminophen is present in >600 OTC and prescription products (NyQuil, Percocet, Vicodin, DayQuil, Excedrin, many cough/cold medications). Patients must read ALL medication labels to avoid inadvertent double-dosing, which is a major cause of unintentional overdose.

Alcohol Warning: OTC label warns that patients who consume 3 or more alcoholic drinks daily should ask a doctor before using acetaminophen. Chronic alcohol use significantly increases hepatotoxicity risk.

Children's Dosing: Pediatric formulations (children's liquid, infant drops) have different concentrations. ALWAYS check the concentration on the label and use the correct dosing device. Do NOT switch between formulations without recalculating the dose.

Severe Skin Reactions: Though rare, acetaminophen has been associated with Stevens-Johnson syndrome and AGEP. Discontinue immediately if skin reactions develop.

Acetaminophen Black Box Warning

No black box warning on record for Acetaminophen

Other warnings & precautions

Acetaminophen Black Box Warning

No black box warning on record for Acetaminophen

Other warnings & precautions