Medline
- Dosage form
- TABLET
- Labeler
- Medline Industries, LP
- Label updated
- 2026-07-20
- Retrieved
- 2026-09-07
- Active ingredients
- ACETAMINOPHEN
Active ingredient (in each tablet)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- backache
- toothache
- premenstrual and menstrual cramps
- headache
- minor pain of arthritis
- muscular aches
- 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 the product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If skin reaction occurs, stop use and seek medical helps 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 healthcare 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 take more than directed (see overdose warning)
|
adults and children 12 years and older |
|
| children under 12 years |
|
Other information
- store between 20-25ºC (68-77ºF)
- protect from freezing, avoid excessive heat
Inactive ingredients
povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Questions or comments?
call 1-800-MEDLINE (633-5463) Monday - Friday, 7 a.m. to 7 p.m. CST
Manufacturing information
www.medline.com
©2026 Medline
Manufactured for: Medline Industries, LP, Three Lakes Drive,
Northfield, IL 60093 USA
1-800-MEDLINE
**this product is not manufactured
or distributed by Johnson & Johnson Consumer Inc.,
distributor of Tylenol® Extra Strength Tablets
Package Label
[Image in the official label — see DailyMed source]
[Image in the official label — see DailyMed source]
DailyMed Set ID: 4b1d7243-b943-4e2b-e063-6294a90a2c4e · Version 2
NDC: 53329-604