Active Ingredient (In Each Tablet)
Acetaminophen 500 mg
Medline Tablet
FDA Label NDC 53329-195
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 53329-195). 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 the user, ask a doctor or pharmacist before use if, 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
for the temporary relief of minor aches and pains associated with
- the common cold
- the flu
- headache
- toothache
- muscular aches
- backache
- the premenstrual and menstrual periods
- for the minor pain from arthritis
- to reduce fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 milligrams in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everday while using this product
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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
- for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
Ask A Doctor Before Use If The User
- has liver disease
- is a child with pain of arthritis
Ask A Doctor Or Pharmacist Before Use If
- the user is 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
- redness or swelling is present
- symptoms do not improve
- any new symptoms appear
If Pregnant Or Breast-Feeding,
ask a 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
| adults and children 12 years and over |
|
| children under 12 years |
|
Other Information
- store between 20-25°C (68-77°F)
- not made with Natural Rubber Latex
- do not use if inner seal is broken or missing
Inactive Ingredients
hydroxy propyl methyl cellulose, polyethylene glycol, pregelatinised starch, providone K-30, purified water, sodium starch glycolate, stearic acid
Manufacturer Information
www.medline.com ©2023 Medline Industries, LP.
Made in India. Manufactured for Medline Industries, LP,
Three Lakes Drive, Northfield IL 60093 USA
1-800-MEDLINE V1 RJ23HND
* Please review the disclaimer below.
