Aspirin (AS-pir-in), Butalbital (bue-TAL-bi-tal), Caffeine (KAF-een), Codeine Phosphate (KOE-deen FOS-fate)

Treats tension headaches. This medicine contains an NSAID and a narcotic pain reliever.

Brand Name(s):

Ascomp w/Codeine

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed. An overdose can be dangerous. Follow directions carefully so you do not get too much medicine at one time. Your doctor may also give naloxone to treat an overdose.
• This medicine is not for long-term use.
• This medicine works best if you take it at the first sign of headache or pain.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the medicine in a safe and secure place. Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA website for locations. Here is the link to the FDA safe disposal of medicines web site: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are using or have used an MAO inhibitor within the past 14 days.
• Some medicines can affect how this medicine works. Tell your doctor if you are using any of the following:
  • 6-mercaptopurine, acetazolamide, amiodarone, amphotericin B, bacitracin, bupropion, carbamazepine, cisplatin, cyclosporine, erythromycin, fluoxetine, foscarnet, ketoconazole, methazolamide, methotrexate, mirtazapine, paroxetine, phenytoin, probenecid, quinidine, rifampin, ritonavir, sulfinpyrazone, tramadol, trazodone, valproic acid, vancomycin injection
  • Benzodiazepine medicine
  • Blood pressure medicine (including captopril, metoprolol, propranolol, ramipril)
  • Blood thinner medicine (including apixaban, clopidogrel, enoxaparin, heparin, prasugrel, rivaroxaban, warfarin)
  • Diuretic (water pill)
  • Insulin or oral diabetes medicine
  • Medicine to treat anxiety, depression, or mental health problems (including SNRIs, SSRIs, TCAs)
  • Medicine to treat infection
  • Other NSAID pain or arthritis medicine (including diclofenac, ibuprofen, ketorolac, naproxen)
  • Phenothiazine medicine
  • Steroid medicine (including hydrocortisone, methylprednisolone, prednisolone, prednisone)
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are using buprenorphine, butorphanol, nalbuphine, pentazocine, or a muscle relaxer.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant. Do not use this medicine during the later part of a pregnancy, unless your doctor tells you to.
• Do not breastfeed while you are using this medicine, unless you have your doctor's permission to do so.
• Tell your doctor if you have kidney disease, liver disease, Addison disease, lung or breathing problems (including asthma, COPD, sleep apnea), gallbladder problems, pancreas problems, an enlarged prostate, trouble urinating, an underactive thyroid, or stomach problems. Tell your doctor if you have a history of depression, head injury, seizures, or a history of drug or alcohol abuse.
• This medicine may cause the following problems:
  • High risk of overdose, which can lead to death
  • Respiratory depression (serious breathing problem that can be life-threatening)
  • Serotonin syndrome, when used with certain medicines
  • Sleep-related breathing problems (including sleep apnea, sleep-related hypoxemia)
  • Adrenal gland problems
  • Low blood pressure
  • Seizures
  • Stomach or bowel problems (including bleeding, ulcers, or perforation)
  • Serious skin reaction, including drug reaction with eosinophilia and systemic symptoms (DRESS)
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children. This medicine may also cause a delay in ovulation for women and may affect their ability to have children.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fever, muscle spasms, twitching, nausea, vomiting, diarrhea, seeing or hearing things that are not there
• Blistering, peeling, red skin rash
• Bloody or black, tarry stools
• Blue lips, fingernails, or skin
• Changes in skin color, dark freckles, cold feeling, tiredness, weight loss
• Change in how much or how often you urinate, painful urination
• Extreme dizziness or weakness, shallow breathing, slow or uneven heartbeat, sweating, cold or clammy skin, seizures
• Lightheadedness, dizziness, fainting
• Severe constipation or stomach pain
• Unusual bleeding, bruising, or weakness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088