FDA Label for Medline

Active Ingredient (In Each Caplet)

Acetaminophen 500 mg

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 everyday while using this product

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.

Ask A Doctor Before Use If The User

• has liver disease
• is a child with pain of arthritis

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 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

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