TYLENOL EXTRA STRENGTH
- Dosage form
- TABLET
- Labeler
- R J General Corporation
- Label updated
- 2025-11-17
- Retrieved
- 2026-09-07
- Active ingredients
- ACETAMINOPHEN
Label information
Drug Facts
Active ingredient (in each caplet)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- headache
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
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
Label information
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
Label information
Ask a doctor before use if you haveliver disease
Label information
Ask a doctor or pharmacist before use if you aretaking 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.
Label information
If pregnant or breast-feeding,ask a health professional before use.
Label information
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 take more than directed (see overdose warning)
| adults and children 12 years and over |
|
| children under 12 years | ask a doctor |
Other information
- store between 20-25°C (68-77°F)
- do not use if pouch is torn or damaged
Inactive ingredients
carnauba wax contains one or more of these ingredients, corn starch , FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch , polyethylene glycol , powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide
Questions or comments?
call 1-877-895-3665(toll-free) or 215-273-8755(collect)
Label information
Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
McNeil Consumer Healthcare Division
Fort Washington, PA 19034 USA
Repackaged and distributed by:
RJ General
2024 Northwest Drive
Cincinnati OH 45231
PRINCIPAL DISPLAY PANEL - 500 mg Caplet Pouch Box
TYLENOL
®
FOR ADULTS
Acetaminophen
Pain Reliever
Fever Reducer
Extra Strength
50 Pouches of
2 Caplets each
500 mg each
Do not use if pouch is torn or damaged.
[Image in the official label — see DailyMed source]
DailyMed Set ID: 99e45e83-37a3-44df-9a2a-98ba7457a5bb · Version 4
NDC: 70264-027