Label: ACETAMINOPHEN, ASPIRIN AND CAFFEINE tablet

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Pain reliever

Pain reliever

Pain reliever aid

• 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. 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 heart beat.

• 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:

o diabetes

o gout

o 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

• an allergic reaction occurs. Seek medical help right away.

• you experience any of the following signs of stomach bleeding :

o feel faint

o vomit blood

o have bloody or black stools

o 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

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.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

• do not use more than directed

• adults: take 2 caplets with a glass of water

• if symptoms persist or worsen, ask your doctor

• do not take more than 2 caplets in 24 hours, unless directed by a doctor

• under 18 years of age: ask a doctor

• store at controlled room temperature 20° to 25°C (68° to 77°F)

• close cap tightly after use

• read all product information before using. Keep this box for important information.

• Tamper Evident : Do not use if foil inner seal under the cap is opened or missing

Carnauba wax, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, propylene glycol, sodium stearyl fumarate and titanium dioxide

Contact 1-844-384-3273 Mon-Fri 8:00 AM EST to 5:00 PM PST


Distributed By:

Safrel Pharmaceuticals, LLC

Bridgewater, NJ 08807