M357 (Acetaminophen and Hydrocodone 500 mg / 5 mg)

Hydrocodone/acetaminophen is an inexpensive drug used to treat moderate to severe pain. It is more popular than comparable drugs and is available in multiple generic and brand versions.

It contains hydrocodone, an opioid (narcotic) and acetaminophen, an analgesic (pain reliever and fever reducer). Both drugs are used to reduce pain and work in your brain to block pain signals and decrease one’s ability to feel pain.

This drug is a prescription medication and a controlled substance. It belongs to the drug class narcotic analgesic combinations and is available in oral tablet and oral solution.


  • This drug is available in generic form, and therefore, costs less.
  • A combination of this drug is effective at relieving moderate-to-moderately severe pain.
  • Acetaminophen/hydrocodone combination is more effective than either drug alone.
  • Both drugs last for a similar length of time in the body which makes them appropriate to be given together.


  • Other generic forms of this drug may not be available in every strength or form as the brand.
  • Excessive doses of acetaminophen can cause liver damage or death.
  • Hydrocodone component of this medicine causes stomach upsets including nausea, vomiting, and constipation; shortness of breath; dizziness; low blood pressure.
  • Unlike NSAID pain relievers (ex. Ibuprofen); acetaminophen does not have any appreciable anti-inflammatory action.
  • This drug is habit-forming and misuse can cause addiction/dependence, overdose and even death.


In general, older adults, children, and people with certain medical conditions or people who take other medications are more at risk of developing a wider range of side effects. This medicine is not intended for use in children 6 years old and below for risk of slow or shallow breathing.

Nausea, vomiting, constipation, lightheadedness, dizziness, or drowsiness may occur. Some side effects tend to disappear with regular use of this medicine and some people may not experience these side effects. Consult the doctor if you feel worsening of symptoms or if you feel other side effects not listed in this section.

Seek emergency help with these serious side effects:

  • shallow breathing, slow heartbeat;
  • feeling light-headed, fainting;
  • confusion, fear, unusual thoughts or behavior;
  • seizure (convulsions);
  • problems with urination; or
  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
  • allergic reaction such as hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Get help in case you experience these overdose symptoms: extreme drowsiness, sweating, pinpoint pupils, nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes), confusion, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, coma, blue lips, shallow breathing, or no breathing.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


  • Take only as prescribed and as directed. Do not increase your dose, take the medication more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.
  • Withdrawal symptoms may be experienced when the medicine has been used for a long time and in high doses. Report to your doctor these symptoms right away.
  • Inform the doctor if you are allergic to acetaminophen/hydrocodone or to other opioids and to other substances.
  • Tell the doctor your medical history and the medicines taken.
  • This drug causes drowsiness and dizziness. Avoid alcohol. Do not drive, operate machineries or do activities that require alertness until you know how this drug affects you.
  • Inform your doctor/dentist about the products you use (including prescription/non-prescription drugs, vitamins, supplements, herbal products, etc.) before undergoing treatment, surgery, or dental extraction.
  • Children and older adults are sensitive to side effects of slow/shallow breathing.
  • Caution with use among elderly due to risk of falls and accidents. This medicine can cause drowsiness, confusion, and dizziness.
  • This medicine can harm the unborn baby. Discuss with your doctor the risks and benefits of this medicine and if you are pregnant, planning to get pregnant, or if you feel that you may be pregnant.
  • Acetaminophen/hydrocodone passes into breast milk. Consult your doctor before breastfeeding.
  • Keep out of the reach of children and pets.
  • Discard unused and expired medicines properly.
  • Store acetaminophen and hydrocodone at room temperature away from moisture and heat.

Pain medications work best when used at the first sign of pain. Discuss with your treating physician the risks and benefits involved in taking this medication. Tell the doctor if the medicine doesn’t seem to work or if the pain persists or worsens.


This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.


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