Description

Product Overview

Hydrocodone 5 mg/500 mg is a prescription combination medicine containing 5 mg of hydrocodone and 500 mg of acetaminophen per tablet. Hydrocodone is an opioid analgesic, while acetaminophen is a non-opioid pain reliever.

This formulation has been used historically for the treatment of pain when an opioid-containing medicine was considered appropriate. Because hydrocodone can cause serious adverse effects, including respiratory depression, misuse, addiction, tolerance, and physical dependence, it should only be used under professional medical supervision.

For general information about hydrocodone combination medicines, see MedlinePlus.

Active Ingredients

Each tablet contains:

• Hydrocodone: 5 mg
• Acetaminophen: 500 mg

The inactive ingredients, tablet color, shape, imprint, and labeling may vary by manufacturer. Patients should verify the specific product information on their prescription label.

Manufacturer-submitted medication labeling can be reviewed through DailyMed.

How Hydrocodone 5/500 mg Works

Hydrocodone acts on opioid receptors in the central nervous system and changes how the brain and body perceive pain.

Acetaminophen provides additional analgesic activity through a different mechanism. Together, the two ingredients can provide pain-relieving effects.

Because hydrocodone is an opioid, treatment requires careful attention to dosing, interactions, duration of use, and individual risk factors.

Important Safety Information

Hydrocodone can cause serious or life-threatening respiratory depression, particularly when taken incorrectly or combined with other substances that depress the central nervous system.

Potential warning signs include:

• Very slow or shallow breathing
• Unusual difficulty staying awake
• Difficulty waking
• Loss of consciousness
• Severe confusion
• Blue, gray, or pale lips or skin

Suspected opioid overdose requires immediate emergency medical attention.

The FDA’s opioid medication safety information provides additional information about opioid risks.

Acetaminophen and Liver Safety

The 500 mg acetaminophen component is also important to consider.

Taking too much acetaminophen can cause severe liver injury, and the risk may increase when multiple acetaminophen-containing products are taken together.

Before using another pain reliever or cold/flu product, patients should check its active ingredients for acetaminophen. A doctor or pharmacist can help determine whether combining products is appropriate.

Additional information is available from the FDA’s acetaminophen safety resources.

Possible Side Effects

Potential side effects associated with hydrocodone/acetaminophen include:

• Drowsiness
• Dizziness
• Nausea
• Vomiting
• Constipation
• Lightheadedness
• Sleepiness

Side effects can vary from person to person.

Severe sedation, breathing difficulties, fainting, or inability to wake should be treated as potentially serious symptoms.

Dependence, Tolerance and Misuse

Hydrocodone can result in physical dependence with repeated use. Tolerance can also develop, meaning the body may respond differently to a medicine after continued exposure.

Physical dependence is different from addiction, although opioids also carry a risk of developing opioid use disorder.

Patients should never increase the amount or frequency of hydrocodone on their own. Anyone who has been taking an opioid regularly should consult their healthcare professional before making changes or stopping treatment.

Alcohol and Drug Interactions

Alcohol can increase the sedating effects of hydrocodone and may increase the risk of dangerous respiratory depression.

Other medicines that cause sedation can also interact with opioids. This is particularly important for medicines such as benzodiazepines and other central-nervous-system depressants.

Provide your doctor or pharmacist with a complete list of prescription medicines, over-the-counter products, supplements, and substances you use.

The CDC’s opioid clinical guidance provides additional information about opioid safety and risk assessment.

Driving and Operating Machinery

Hydrocodone may cause drowsiness, dizziness, impaired judgment, or slower reaction times.

Patients should follow their healthcare professional’s advice about driving or operating machinery. Extra caution is appropriate when starting treatment or when the prescribed regimen changes.

Storage and Disposal

Prescription opioids should be stored securely and kept away from children and anyone for whom the medicine was not prescribed.

Never share prescription medication with another person.

For information about safely disposing of unused medicines, consult the FDA Safe Disposal of Medicines.

Frequently Asked Questions

What is Hydrocodone 5/500 mg?

It is a prescription combination medicine containing 5 mg of hydrocodone and 500 mg of acetaminophen per tablet.

Is Hydrocodone 5/500 mg an opioid?

Yes. Hydrocodone is an opioid analgesic.

Does Hydrocodone 5/500 mg contain acetaminophen?

Yes. Each tablet contains 500 mg of acetaminophen.

Can Hydrocodone cause dependence?

Yes. Repeated opioid exposure can result in physical dependence, and hydrocodone also carries risks of misuse and addiction.

Can additional acetaminophen be taken with it?

Patients should not automatically take additional acetaminophen because the combination already contains 500 mg per tablet. Ask a healthcare professional or pharmacist before using another acetaminophen-containing medicine.

What should I do if an overdose is suspected?

Call emergency medical services immediately. In the United States, call 911. If naloxone is available, use it according to its instructions while emergency assistance is being obtained.

Important Note About This Strength

Hydrocodone/acetaminophen 5 mg/500 mg is an older formulation. U.S. regulatory changes led manufacturers to reduce the amount of acetaminophen in prescription combination opioid products because of concerns about acetaminophen-related liver injury. Therefore, availability and labeling for older 5/500 mg products may differ from newer formulations.

Always verify the exact medicine and strength with a licensed pharmacist or prescriber rather than relying solely on an online product description.

Final Summary

Hydrocodone 5 mg/500 mg combines 5 mg of hydrocodone with 500 mg of acetaminophen. Hydrocodone carries important opioid-related risks, including respiratory depression, sedation, misuse, addiction, tolerance, and physical dependence. The acetaminophen component creates an additional risk of liver injury when excessive amounts are consumed.

For safe use, follow the prescribing instructions exactly, avoid combining medicines without professional guidance, check other products for acetaminophen, and seek emergency help if an opioid overdose is suspected.