Hydrocodone/Acetaminophen Oral Tablet 5 mg/400 mg, 7.5 mg/325 mg, 7.5 mg/500 mg, 7.5 mg/650 mg, 10 mg/300 mg, 10 mg/325 mg, 10 mg/500 mg, 10 mg/650 mg, 10 mg/660 mg

Instructions

This medicine may be taken with or without food.

Keep the medicine at room temperature. Avoid heat and direct light.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

To reduce constipation, eat high fiber foods, drink plenty of water and exercise.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Do not take more than 6 pills in a day.

Cautions

This medicine has an opioid. Opioids help many people but may cause addiction, especially if used for a long time. The addiction risk is higher if you have a substance use disorder (overuse of or addiction to drugs or alcohol). Ask your doctor about the benefits and risks.

Ask your doctor or pharmacist if you should have naloxone on hand to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.

If you stop this medicine suddenly after using it for a long time, you may have withdrawal. Your doctor may slowly lower your dose before stopping it. Tell your doctor right away if you have symptoms, such as unusual sweating, watering eyes, runny nose, chills, diarrhea, yawning, muscle aches, restlessness, anxiety, trouble sleeping, or thoughts of suicide.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Do not use the medication any more than instructed.

If possible, avoid using with alcohol, marijuana, or other medicines that can cause dizziness or drowsiness. These include allergy/cold products, muscle relaxers, sleep aids, and pain relievers.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not operate machinery or drive while on this medicine.

This medicine passes into breast milk. Ask your doctor before breastfeeding.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

This medicine should be used with caution in patients with breathing difficulties.

Call your doctor right away if you notice slow or shallow breathing.

Do not share this medicine with anyone who has not been prescribed this medicine.

This medicine contains acetaminophen. There are many medicines with acetaminophen. Taking these medicines together can cause you to get too much acetaminophen. This can cause serious liver problems. Look carefully on the package of all your medicines to see if acetaminophen is included. Ask your pharmacist which medicines you can take safely.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• constipation
• dizziness or drowsiness
• lack of energy and tiredness
• itching
• nausea and vomiting
• red, burning, or itchy skin
• stomach upset or abdominal pain

If you have any of the following side effects, you may be getting too much medicine. Please contact your doctor to let them know about these side effects.

• changes in memory, mood, or thinking
• difficulty concentrating
• confusion
• fainting
• slow heartbeat
• low blood pressure
• muscle weakness
• blurring or changes of vision

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• decreased awareness or responsiveness
• breathing interruption during sleep
• shallow, irregular breathing
• chest pain
• hallucinations (unusual thoughts, seeing or hearing things that are not real)
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• seizures
• shortness of breath
• light colored stool
• difficulty or discomfort urinating
• severe or persistent vomiting

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.