Apadaz

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Apadaz Warnings

Benzhydrocodone/acetaminophen has a risk for abuse and addiction, which can lead to overdose and death. Benzhydrocodone/acetaminophen may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of benzhydrocodone/acetaminophen that works, and take it for the shortest possible time. See also How to Use section for more information about addiction.

The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you take the wrong dose/strength. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Also, other medications can affect the removal of benzhydrocodone/acetaminophen from your body, which may affect how benzhydrocodone/acetaminophen works. Be sure you know how to take benzhydrocodone/acetaminophen and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this drug, get medical help right away.

One ingredient in this product is acetaminophen. Taking too much acetaminophen may cause serious (possibly fatal) liver disease. Adults should not take more than 4000 milligrams (4 grams) of acetaminophen a day. People with liver problems and children should take less acetaminophen. Ask your doctor or pharmacist how much acetaminophen is safe to take.

Do not use with any other drug containing acetaminophen without asking your doctor or pharmacist first. Acetaminophen is in many nonprescription and prescription medications (such as pain/fever drugs or cough-and-cold products). Check the labels on all your medicines to see if they contain acetaminophen, and ask your pharmacist if you are unsure.

Get medical help right away if you take too much acetaminophen (overdose), even if you feel well. Overdose symptoms may include nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, and dark urine.

Daily alcohol use, especially when combined with acetaminophen, may damage your liver. Avoid alcohol.

Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn't stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.
  • CAUTION: Opioid. Risk of overdose and addiction.
  • May cause drowsiness and dizziness. Alcohol and marijuana may intensify this effect. Use care when operating a vehicle, vessel (e.g., boat), or machinery.
  • Contains Acetaminophen. Don't use with other drugs that contain Acetaminophen (prescription or nonprescription) unless doctor approves. Too much can cause liver damage
  • If you are pregnant or of childbearing age, discuss the risks/benefits of this medication with your doctor and pharmacist.
  • Using more of this medication than recommended may cause serious breathing problems.
  • Do not drink alcoholic beverages when using this medication.
  • CAUTION: Ask your doctor before using this drug with other opioids, sleep or anxiety drugs, or other drugs that can cause serious breathing problems/drowsiness.
  • Read the boxed warning information for this medication.

Lactation Warnings

  • MONITOR FOR CHANGES IN RESPIRATION, GI EFFECTS, SEDATION, FEEDING PATTERNS

Pregnancy Warnings

  • Insufficient human data available. May precipitate withdrawal symptoms in fetus and opioid dependent mother. Consider maternal treatment benefits versus potential fetal/neonatal adverse outcomes. Insufficient animal data available.