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

FDA is informing manufacturers, members of the medical and scientific community, and other interested persons that at this time we do not intend to object to the marketing of single- and combination-ingredient, acetaminophen-containing, nonprescription (commonly referred to as over-the-counter (OTC)) drug products bearing a warning as described in this guidance (see 22 section III, Discussion and Policy) alerting consumers that the use of acetaminophen may cause severe skin reactions.

This guidance is intended to apply to single- and combination-ingredient acetaminophen-containing products marketed under the Tentative Final Monograph (TFM) for Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) Drug Products for Over-the-Counter Human Use, published in the Federal Register (53 FR 46204, November 16, 1988).

FDA Recommendation

FDA recommends that manufacturers of all acetaminophen-containing OTC drug products marketed pursuant to the TFM for IAAA Drug Products (both single- and combination-ingredient acetaminophen products) include language in labeling warning consumers that acetaminophen may cause severe skin reactions.

At this time, FDA does not intend to object to the marketing of products containing the following warning language described below:

  • Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: [bullet] skin reddening [bullet] blisters [bullet] rash
  • If a skin reaction occurs, stop use and seek medical help right away. 

This guidance does not address alternative warning language that may otherwise misbrand the product.

This recommended warning should appear under the “Warnings” heading section of the Drug Facts label under the subheading “Allergy Alert” and directly follow the liver warning (21 CFR 88 201.326) on acetaminophen-containing drug products. FDA recommends that this warning be 89 included on all packaging configurations.

 
 

EXAMPLE OTC DRUG FACTS LABEL WITH RECOMMENDED WARNING

Drug Facts

Active Ingredient (in each [insert dosage form])                                        Purpose
Acetaminophen XXX mg……………………………………….………………Pain reliever/fever reducer

Uses

(Insert as described in an applicable OTC drug monograph or approved drug application.)

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than [insert quantity and dosage form] in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if you have

  • liver disease

Ask a doctor or pharmacist before use if

  • you are taking the blood thinning drug warfarin

Stop using and ask a doctor if

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse

If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

(Insert as described in an applicable OTC drug monograph or approved drug application.)

Other Information

(Insert any additional information that is not included under the other subheadings but which is required or is made optional under an OTC drug monograph(s), other OTC drug regulation(s), approved drug application, statute, or OTC drug guidance.)

Inactive Ingredients

(Insert a list of each inactive ingredient, using its established name.)

Questions or Comments

(Insert optional heading used to provide a telephone number of a source to answer questions about the drug product or to receive reports of adverse events associated with the use of the drug product.)

FDA Recommended Warning for OTC Acetaminophen-Containing Drug Products