Active Ingredient (In Each Tablet)
Acetaminophen 500 mg
Medline Tablet
FDA Label NDC 53329-604
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Medline (NDC 53329-604). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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)
- take 2 tablets every 6 hours while symptoms last
- do not take more than 6 tablets in 24 hours, unless directed by a doctor
- do not use more than 10 days unless directed by a doctor
- ask a doctor
adults and children 12 years and older | |
| children under 12 years |
Other Information
- store between 20-25°C (68-77°F)
- 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
* Please review the disclaimer below.
