Aspirin (AS-pir-in), Caffeine (KAF-een), Dihydrocodeine Bitartrate (dye-hye-droe-KOE-deen bye-TAR-trate)

Treats moderate to severe pain. Dihydrocodeine is a narcotic pain reliever.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• 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.
• It is best to take this medicine with food or milk.
• This medicine is not for long-term use.
• 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. 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 web site 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:
  • Acetazolamide, amiodarone, amphotericin B, bacitracin, carbamazepine, cisplatin, cyclosporine, erythromycin, foscarnet, ketoconazole, methazolamide, methotrexate, mirtazapine, phenytoin, probenecid, quinidine, rifampin, ritonavir, tramadol, trazodone, valproic acid, or vancomycin
  • Benzodiazepine medicine
  • Blood pressure medicine (including ACE inhibitors, beta blockers)
  • Blood thinner (including apixaban, clopidogrel, enoxaparin, heparin, prasugrel, rivaroxaban, warfarin)
  • Diuretic (water pill)
  • Insulin or other diabetes medicine (including glimepiride, glipizide)
  • Medicine to treat depression or mental health problems (including bupropion, fluoxetine, paroxetine, SNRIs, SSRIs, TCAs)
  • Medicine to treat infection
  • Other NSAID medicine (including diclofenac, ibuprofen, ketorolac, naproxen)
  • Phenothiazine medicine
  • Steroid medicine (including dexamethasone, hydrocortisone, methylprednisolone, prednisone)
• Do not drink alcohol while you are using this medicine. Alcohol combined with this medicine may cause life-threatening problems.
• 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 also using buprenorphine, butorphanol, nalbuphine, pentazocine, or a muscle relaxer (including cyclobenzaprine, metaxalone).

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 your doctor tells you to.
• Tell your doctor if you have kidney disease, liver disease, blood clotting problems, lung or breathing problems (including COPD, sleep apnea), heart disease, low blood pressure, gallbladder or pancreas problems, stomach ulcers, or a history of alcohol or drug abuse, brain tumor, head injury, depression, mental health problems, or seizures.
• 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)
  • Sleep-related breathing problems (including sleep apnea, sleep-related hypoxemia)
  • Worsening of pain
  • 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)
  • Kidney problems
  • Serotonin syndrome, when used with certain medicines
• This medicine may make you dizzy, drowsy, or lightheaded. 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 can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• 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, fast heartbeat, fever, muscle spasms, twitching, diarrhea, seeing or hearing things that are not there
• Blistering, peeling, or red skin rash
• Bloody, black, or tarry stools, coughing up blood, vomiting of blood or material that looks like coffee grounds
• Blue lips, fingernails, or skin
• Change in how much or how often you urinate, painful urination
• Changes in skin color, dark freckles, cold feeling, tiredness, weight loss
• Confusion, trouble breathing, numbness or tingling in your hands, feet, or lips
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Extreme dizziness, drowsiness, or weakness, shallow breathing, slow or uneven heartbeat, seizure, sweating, cold, clammy skin
• Lightheadedness or fainting
• Tremors, muscle cramps
• Unusual bleeding or bruising
• Worsening of pain, increased sensitivity to pain

If you notice these less serious side effects, talk with your doctor:

• Constipation, nausea

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