Source: OpenFDA label data · Not medical advice · For personal tracking only
Important warning themes extracted from the FDA label. Review the full label warnings below for source wording.
Severe liver damage may occur if ■ adult takes more than 4,000 mg of acetaminophen in 24 hours ■ child takes more than 5 doses in 24 hours, which is the maximum daily amount ■ taken with other drugs containing acetaminophen ■ adult has 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.
These may signal more serious reactions and may require prompt medical attention.
Also mentioned in the drug label or warning text.
Small fluid-filled pockets that form on or under the skin.
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Source label wording. This may be long, technical, or formatted for the original package label.
Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if ■ adult takes more than 4,000 mg of acetaminophen in 24 hours ■ child takes more than 5 doses in 24 hours, which is the maximum daily amount ■ taken with other drugs containing acetaminophen ■ adult has 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 are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if the user ■ has liver disease ■ is a child with pain of arthritis Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin When using this product do not exceed recommended dose (see overdose warning) Stop use and ask a doctor if ■ pain gets worse or lasts more than 10 days in adults ■ pain gets worse or lasts more than 5 days in children under 12 years ■ fever gets worse or lasts more than 3 days ■ new symptoms occur ■ redness or swelling is present 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. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Directions ■ do not give more than directed (see overdose warning) ■ shake well before using ■ mL = milliliter ■ Children 2 years to under 12 years: ■ find right dose on chart below. If possible, use weight to dose; otherwise, use age. ■ remove the child protective cap and squeeze the dose into the dosing cup ■ repeat dose every 4 hours while symptoms last ■ do not take more than 5 times in 24 hours unless directed by a doctor ■ do not take for more than 5 days unless directed by a doctor Weight (lb) Age (years) Dose (mL)* under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11 years 15 mL * or as directed by a doctor ■ Adults and children 12 years and over: ■ take 20 mL (2 x 10 mL) every 4 hours while symptoms last. For adult dosing,the dosing cup needs to be filled to 10 mL line twice. ■ do not take more than 5 doses (100 mL) in 24 hours unless directed by a doctor ■ do not take for more than 10 days unless directed by a doctor Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
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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.
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Not dosing guidance. Follow your clinician, pharmacist, or product label.