Tylenol
Acetaminophen · Tablet, Film Coated · Oral
Active ingredient
Active ingredient (in each tablet) Acetaminophen 325 mg
Purpose
Purpose Pain reliever/fever reducer
Uses
Uses temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever
Warnings
Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. 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. 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 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.
Do not use
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
Ask a doctor before use if the user has liver disease is a child with pain of arthritis
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
Stop use and ask a doctor
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.
Pregnancy or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
Keep out of reach of children.
Directions
Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children 6 years to under 12 years take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours do not use for more than 5 days unless directed by a doctor children under 6 years ask a doctor
Other information
Other information store between 20-25°C (68-77°F) do not use if carton is opened. Do not use if foil inner seal imprinted with "TYLENOL" is broken or missing
Inactive ingredients
Inactive ingredients magnesium stearate, modified starch, powdered cellulose, pregelatinized starch, sodium starch glycolate
Questions?
Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
Label text from the FDA structured product label by Kenvue Brands LLC (revised May 27, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 9 products
- Guaifenesin in 1 product
- Phenylephrine Hydrochloride in 1 product
Tylenol NDC products (9)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50580-451 | Acetaminophen 500 mg/1 Tablet, Coated | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
| 50580-458 | Acetaminophen 325 mg/1 Tablet, Film Coated | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
| 50580-475 | Acetaminophen 325 mg/1 Tablet, Film Coated | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
| 50580-488 | Acetaminophen 500 mg/1 Tablet, Coated | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
| 50580-495 | Acetaminophen 325 mg/1 Tablet | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
| 50580-496 | Acetaminophen 325 mg/1 Tablet | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
| 50580-566 | Acetaminophen 325 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
| 50580-590 | Acetaminophen 500 mg/1 Tablet, Film Coated | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
| 50580-692 | Acetaminophen 500 mg/1 Tablet, Film Coated | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Tylenol used for?
Uses temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever
Who makes Tylenol?
Tylenol is listed by 1 labeler in the FDA NDC directory, including Kenvue Brands LLC.