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:

CVS PHARMACY, INC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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
CVS PHARMACY, INC
----------
MIGRAINE RELIEF
ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE TABLETS, USP
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 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.