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Tylenol Cold Plus Flu Plus Chest Congestion

Source: OpenFDA label data · Not medical advice · For personal tracking only

The most user-facing sections are shown first. FDA professional label details are kept below and collapsed because they can be technical, repetitive, or difficult to read out of context.

Safety Warning Highlights

6

Important warning themes extracted from the FDA label. Review the full label warnings below for source wording.

Allergy

Allergic ReactionAllergy AlertBlistersRash

Severe liver damage may occur if you take ■ more than 4,000 mg of acetaminophen in 24 hours ■ 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.

Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Reported Side Effects

12

Serious — Get Medical Help

These may signal more serious reactions and may require prompt medical attention.

Other Reported Reactions

Also mentioned in the drug label or warning text.

Allergic Reaction

An immune reaction that may cause rash, swelling, hives, itching, or breathing problems.

FDA label warnings

1

Show full FDA warning text

Source label wording. This may be long, technical, or formatted for the original package label.

Warnings Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4,000 mg of acetaminophen in 24 hours ■ 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. Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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. ■ if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have ■ liver disease ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema ■ cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dose Stop use and ask a doctor if ■ pain or cough gets worse or lasts more than 7 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur ■ cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

Professional label: Usage and Indications

1

Show FDA label use text

Technical label wording. It may be incomplete, repetitive, or written for clinicians.

This is original FDA label wording organized for display. It is not a plain-language summary.

  • Uses ■ temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive ■ temporarily reduces fever

Professional label: Dosage Details

2

Show FDA label dosage text

Not dosing guidance. Follow your clinician, pharmacist, or product label.

This is original FDA label wording organized for display. It is not a personalized dosing recommendation.

  • Directions ■ do not take more than directed (see overdose warning)
  • Adults and children 12 years and over: ■ take 2 caplets every 4 hours while symptoms last ■ do not take more than 10 caplets in 24 hours Children under 12 years: ■ ask a doctor