Medication Guide

Benzhydrocodone (benz”hye” droe koe’ done) and Acetaminophen (a seet” a min’ oh fen) Tablets, CII

Benzhydrocodone and Acetaminophen Tablets are:

• A strong prescription pain medicine that contains an opioid (narcotic) and the medicine acetaminophen. Benzhydrocodone and Acetaminophen Tablets are used to manage short-term pain (no more than 14 days), when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
• An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Important information about Benzhydrocodone and Acetaminophen Tablets:

• Get emergency help or call 911 right away if you take too much Benzhydrocodone and Acetaminophen Tablets (overdose). When you first start taking Benzhydrocodone and Acetaminophen Tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.
• Never give anyone else your Benzhydrocodone and Acetaminophen Tablets. They could die from taking it. Selling or giving away Benzhydrocodone and Acetaminophen Tablets are against the law.
• Store Benzhydrocodone and Acetaminophen Tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
• Get emergency help right away if you take more than 4,000 mg of acetaminophen in 1 day. Taking Benzhydrocodone and Acetaminophen Tablets with other products that contain acetaminophen can lead to serious liver problems and death.

Do not take Benzhydrocodone and Acetaminophen Tablets if you have:

• severe asthma, trouble breathing, or other lung problems. · an allergy to hydrocodone or acetaminophen.
• a bowel blockage or have narrowing of the stomach or · severe liver problems intestines.

Before taking Benzhydrocodone and Acetaminophen Tablet, tell your healthcare provider if you have a history of:

• head injury, seizures ● liver, kidney, thyroid problems
• problems urinating ● pancreas or gallbladder problems
• abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.

Tell your healthcare provider if you are:

• pregnant or planning to become pregnant. Prolonged use of Benzhydrocodone and Acetaminophen Tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• breastfeeding. Benzhydrocodone and Acetaminophen Tablets passes into breast milk and may harm your baby.
• living in a household where there are small children or someone who has abused street or prescription drugs.
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Benzhydrocodone and Acetaminophen Tablets with certain other medicines can cause serious side effects that could lead to death.

When taking Benzhydrocodone and Acetaminophen Tablets:

• Do not change your dose. Take Benzhydrocodone and Acetaminophen Tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• Take your prescribed dose every 4 to 6 hours as needed for pain. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
• Call your healthcare provider if the dose you are taking does not control your pain.
• If you have been taking Benzhydrocodone and Acetaminophen Tablets regularly, do not stop taking Benzhydrocodone and Acetaminophen Tablets without talking to your healthcare provider.
• Dispose of expired, unwanted, or unused Benzhydrocodone and Acetaminophen Tablets by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While taking Benzhydrocodone and Acetaminophen Tablets DO NOT:

• Drive or operate heavy machinery, until you know how Benzhydrocodone and Acetaminophen Tablets affects you. Benzhydrocodone and Acetaminophen Tablets can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Benzhydrocodone and Acetaminophen Tablets may cause you to overdose and die.
• Do not take other products that contain acetaminophen while taking Benzhydrocodone and Acetaminophen Tablets.