ACETAMINOPHEN, ASPIRIN, CAFFEINE- acetaminophen, aspirin, caffeine tablet, film coated
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
■ temporarily relieves minor aches and pains due to:
■ muscular aches
■ a cold
■ premenstrual and menstrual cramps
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 ■ shock ■ asthma (wheezing)
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.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ with other drugs containing acetaminophen ■ more than 8 caplets in 24 hours, which is the maximum daily amount ■ 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 ■ take more or for a longer time than directed ■ 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
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 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.
Ask a doctor before use if
■ you have liver disease
■ 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 have asthma
■ you are taking a diuretic
Ask a doctor or pharmacist before use if you are
■ taking a prescription drug for diabetes, gout, or arthritis
■ taking any other drug or are under a doctor’s care for any serious condition
Stop use and ask a doctor if
■ you experience any of the following signs of stomach bleeding:
■ feel faint
■ have bloody or black stools
■ vomit blood
■ have stomach pain that does not get better
■ an allergic reaction occurs. Seek medical help right away.
■ ringing in the ears or loss of hearing occurs
■ pain gets worse or lasts for more than 10 days
■ fever gets worse or lasts for more than 3 days
■ painful area is red or swollen
■ any new symptoms appear.
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
■ do not use more than directed
■ drink a full glass of water with each dose
■ adults and children 12 years and over:
■ take 2 caplets every 6 hours
■ do not take more than 8 caplets in 24 hours
■ children under 12 years: ask a doctor
■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
■ use by expiration date on package
hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, starch, stearic acid, talc, titanium dioxide, triglycerides
RETAIN THIS CARTON FOR COMPLETE PRODUCT INFORMATION
Distributed by: RUGBY® LABORATORIES, Livonia, MI 48152
†This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Excedrin®
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
|ACETAMINOPHEN, ASPIRIN, CAFFEINE
acetaminophen, aspirin, caffeine tablet, film coated
|Labeler - Rugby Laboratories (079246066)|