AcetaminophenExtra Strength
- Dosage form
- TABLET, COATED
- Labeler
- FOODHOLD U.S.A., LLC
- Label updated
- 2026-01-29
- Retrieved
- 2026-09-07
- Active ingredients
- ACETAMINOPHEN
Active ingredient (in each gelcap)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- toothache
- muscular aches
- the common cold
- headache
- backache
- minor pain from arthritis
- 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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- blisters
- rash
- skin reddening
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.
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
- any new symptoms appear
- redness or swelling is present
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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
- adults and children 12 years and over
- take 2 gelcaps every 6 hours while symptoms last
- do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
- take 2 gelcaps every 6 hours while symptoms last
- children under 12 years: ask a doctor
Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- avoid high humidity
- use by expiration date on package
Inactive ingredients
croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide
Questions or comments?
1-800-426-9391
Principal Display Panel
CAREONE®
NDC 41520-919-20
Compare to the
active ingredient in
Extra Strength Tylenol®
Rapid Release Gels*
Extra Strength
ACETAMINOPHEN
500 mg
Pain Reliever
Fever Reducer
Contains no aspirin
OUR PHARMACIST
Rx
RECOMMEND
225
GELCAPS
Actual
Size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Kenvue Inc., owner of the
registered trademark Extra Strength Tylenol® Rapid Release Gels.
50844 REV0525B51920
DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC
SALISBURY, NC 28147
For product questions or concerns,
contact us at 1-833-992-3872
Quality guaranteed or your money back.
[Image in the official label — see DailyMed source]
DailyMed Set ID: bc19bd47-69ea-4bcc-8d28-c043c9d32513 · Version 15
NDC: 41520-919