Tylenol 8HR
acetaminophen · Tablet, Film Coated, Extended Release · Oral
Active ingredient
Active ingredient (in each caplet) Acetaminophen 650 mg
Purpose
Purpose Pain reliever/fever reducer
Uses
Uses temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever
Warnings
Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets 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. 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 you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 days 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 you have liver disease
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are 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 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 caplets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor children under 12 years do not use
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 carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, modified starch, povidone, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin
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 Nov 7, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 1 product
Tylenol 8HR NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50580-309 | Acetaminophen 650 mg/1 Tablet, Film Coated, Extended Release | Kenvue Brands LLC | NDA |
Frequently asked questions
What is Tylenol 8HR used for?
Uses temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever
Who makes Tylenol 8HR?
Tylenol 8HR is listed by 1 labeler in the FDA NDC directory, including Kenvue Brands LLC.