ACETAMINOPHEN ASPIRIN CAFFEINE- acetaminophen aspirin caffeine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)

Available from:

WALGREEN CO

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever Pain reliever Pain reliever aid treats migraine Headaches may worsen if this product is used for 10 or more days per month. ■ 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 ■ you have never had migraines diagnosed by a health professional ■ you have a headache that is different from your usual migraines ■ you have the worst headache of your life ■ you have fever and stiff neck ■ you have headaches beginning after or caused by head injury, exertion, coughing or bending ■ you experienced your first headache after the age of 50 ■ you have daily headaches ■ you have a migraine so severe as to require bed rest ■ 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 are taking a diuretic ■ you have asthma ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ you have vomiting with your migraine headache ■ taking a prescription drug for: • diabetes • gout • arthritis ■ under a doctor’s care for any serious condition ■ taking any other drug ■ taking any other product that contains aspirin, acetaminophen or any other pain reliever/fever reducer Stop use and ask a doctor if ■ an allergic reaction occurs. Seek medical help right away. ■ 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 ■ your migraine is not relieved or worsens after first dose ■ new or unexpected symptoms occur ■ ringing in the ears or loss of hearing occurs

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACETAMINOPHEN ASPIRIN CAFFEINE- ACETAMINOPHEN ASPIRIN CAFFEINE TABLET
WALGREEN CO
----------
MIGRAINE RELIEF
ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE TABLETS
PAIN RELIEVER/PAIN RELIVER AID
ACTIVE INGREDIENTS (IN EACH CAPLET)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)**
Caffeine 65 mg
**nonsteroidal anti-inflammatory drug
PURPOSES
Pain reliever
Pain reliever
Pain reliever aid
USE
treats migraine
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:
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.
ALLERGY ALERT:
Aspirin may cause a severe allergic reaction which may include: ■
hives ■ facial swelling
■ asthma (wheezing) ■ shock
LIVER WARNING:
This product contains acetaminophen. Severe liver damage may occur if
you take
■ more than 2 caplets 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
MEDICATION OVERUSE HEADACHE WARNING
Headaches may worsen if this product is used for 10 or more days per
month.
CAFFEINE WARNING
The recommended dose of this product contains about as much caffeine
as a cup of
coffee