A.C.A

Adults (18 years of age and older):

Take 1-2 tablet with a full glass of water when headache pain, migraine symptoms or migraine aura appears. If needed, you can take another 1-2 tablet every 4 to 6 hours. Do not exceed 10 tablets over a period of 24 hours.

Do not use Acetaminophen/Caffeine/Aspirin tablet for more than 4 days without consulting your doctor.

Contraindications

You should NOT be given Acetaminophen/Caffeine/Aspirin tablet if you:

Are allergic to aspirin, acetaminophen, caffeine or any of the other ingredients of this medicine

Have ever had an allergic reaction to other medicines used to treat pain, inflammation or fever, such as salicylates, or any other anti-inflammatory medicines known as NSAIDs such as diclofenac or ibuprofen

Have a stomach or intestinal ulcer, or if you have a history of peptic ulceration

Have noticed blood in your stools or black stools

Are a hemophiliac or suffering from other blood disorders

Have severe heart, liver and kidney problems

Take more than 15 mg methotrexate per week

Are in the last 3 months of pregnancy

Are pediatric patient less than 18 years old who have or who are recovering from chickenpox or flu.

Interactions

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Your doctor may need to change your dose and/or to take other precautions. In some cases, you may have to stop taking one of the medicines. This applies especially to the medicines listed below:

• Any other medicinal product that contains acetaminophen, aspirin or any other pain reliever/ fever reducer
• Oral anticoagulants (e.g., warfarin, apixaban, dabigatran), heparin, thrombolytics (e.g., streptokinase, alteplase, reteplase), or other antiplatelets (e.g., ticlopidine, clopidogrel, cilostazol, dipyridamole, ticagrelor, ticlopidine, tirofiban)
• Corticosteroids (e.g., betamethasone, dexamethasone, methylprednisolone, prednisolone)
• Selective serotonin reuptake inhibitors (e.g., citalopram, escitalopram, fluoxetine), fluvoxamine, duloxetine, paroxetine,
• Some antibiotics (e.g., rifampicin, isoniazid, chloramphenicol, ciprofloxacin, levofloxacin, ofloxacin).
• Epilepsy medication (e.g., acetazolamide, valproate sodium, divalproex, fosphenytoin, phenytoin)
• High blood pressure and heart failure medication (e.g., amiloride, hydrochlorothiazide, amlodipine, aliskiren, atenolol, betaxolol, carvedilol, diltiazem, enalapril, furosemide, losartan, metoprolol, nimodipine, spironolactone)
• Theophylline, terbinafine, cimetidine, disulfiram, nicotine, cholestyramine, clozapine, zidovudine, levothyroxine, metoclopramide, methotrexate, lithium, cyclosporine, pemetrexed, pentoxifylline, tacrolimus, deferasirox, probenecid, propantheline, glyburide and insulin.

Pregnancy and Lactation

Pregnancy:

This medicine is not recommended during pregnancy, especially during the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery.

Lactation:

Do not take Acetaminophen/Caffeine/Aspirin tablet if you are breast-feeding as it might be harmful for your infant.

Warning and Precaution

Talk to your doctor or pharmacist before taking Acetaminophen/Caffeine/Aspirin tablet if you:

• Have not been diagnosed with migraine before, as potentially serious conditions relating to the brain or nerves need to be excluded before treatment
• A headache different from your usual migraines, or if you have vomiting with your migraine headache
• Start having headaches after or caused by head injury, exertion, coughing or bending
• Have chronic headaches (15 days or more per month for more than 3 months), or if you experience your first headache after the age of 50
• Have liver or kidney problems or a severe infection
• Are severely malnourished, are severely underweight, or are a chronic heavy alcohol user, as this may increase the risk of metabolic acidosis
• Suffer from a hereditary condition called glucose 6-phosphate dehydrogenase deficiency
• Have ever had gastrointestinal problems such as stomach ulcer, bleeding or black stools. If you have had stomach discomfort or heartburn after taking pain relievers or anti-inflammatory medicines in the past
• Suffer from bleeding disorders or abnormal vaginal bleeding other than your menstrual period (e.g., unusually heavy and prolonged menstrual period)
• Have recently undergone a surgical operation (including minor ones such dental surgery) or will undergo one within the next 7 days
• Have bronchial asthma, hay fever, nasal polyps, a chronic respiratory disease or develop allergic symptoms
• Have gout, diabetes, hyperthyroidism, arrhythmia, uncontrolled hypertension
• Have alcohol problems
• Are already taking other medicinal products containing acetylsalicylic acid (aspirin) or acetaminophen
• Are at risk of being dehydrated (e.g., by vomiting, diarrhea, or before or after major surgery)

Adverse Reactions

Common:  nervousness, dizziness, nausea, abdominal discomfort

Uncommon: insomnia, trembling, numbness, headache, dry mouth, diarrhea, vomiting, fatigue, heart rate increased

Rare: sore throat, difficulty in swallowing, numbness or tingling around the mouth, too much saliva, decreased appetite, altered taste, anxiety, euphoric mood, tension, disturbance in attention, memory loss, feeling of pain in the cheeks and forehead, eye pain, vision disorder, hot flushes, nose bleeds, slow and shallow breathing, runny nose, flatulence, itching, itchy rash, increased skin sensitivity, stiffness in muscles, bones or joints; neck pain, back pain, muscles spasms, weakness, chest discomfort

Storage

Store below 30°C and protect from light and moisture.