Active ingredient (in each tablet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Uses
- temporarily relieves minor aches and pains due to:
- headache
- sinusitis
- cold
- arthritis
- muscular aches
- toothache
- premenstual and menstrual cramps
Warnings
Reye's Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If skin reaction occurs, stop use and seek medical help right away.
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 tablets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
Caffeine Warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine containing medications, foods or beverages which while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally, rapid heartbeat.
Do not use
- if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
- 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 doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- you have asthma
- you have liver disease
Stop using and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- painful area is red or swollen
- symptoms do not improve
- any new symptoms appear
- pain or fever persists or gets worse
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- if ringing in the ears or a loss of hearing occurs, consult a doctor before taking any more of this product
- fever gets worse or lasts for more than 3 days
- pain gets worse or lasts for more than 10 days
Directions
- do not use more than directed
- drink a full glass of water with each dose
- adults and children 12 years and over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours
- children under 12 years: do not use unless directed by a doctor
Inactive ingredients
carnauba wax, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
Manufacturing Information
Manufactured for:
Medline Industries, LP
Three Lakes Drive, Northfield, IL 60093 USA
Made in USA with domestic and foreign materials
www.medline.com
1-800-MEDLINE (633-5463)
REF: OTCM00013
V1 RE22HND
†This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin® Extra Strength.
