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Empracet (Generic Acetaminophen and Codeine)

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Acetaminophen and codeine may become habit-forming when taken together, especially over an extended period of time. Acetaminophen and codeine must be taken exactly as prescribed. Never exceed your doctor’s recommended dosage, frequency, or method of administration. Talk to your doctor about additional pain management options while taking acetaminophen and codeine. Also, consider the length of your therapy and your pain management goals. Inform your doctor if you or any family members currently or in the past have used excessive amounts of alcohol, street drugs, abused prescription medications, experienced an overdose, or have depression or another mental condition. If you currently have or have ever had any of these illnesses, you are more likely to misuse acetaminophen and codeine. If you suspect that you may have an opioid addiction, speak with your doctor right away and ask for advice, or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.

Acute or potentially fatal breathing issues can result with taking acetaminophen and codeine together, especially in the first 24 to 72 hours of treatment and if your dose is raised. Throughout your therapy, your doctor will keep a close eye on you. If you have asthma or slow breathing, let your doctor know. Most likely, your doctor will advise against using acetaminophen and codeine. Additionally, let your physician know if you now have or previously had a lung condition like chronic obstructive pulmonary disease (COPD), a group of illnesses that affect the lungs and airways, a head injury, a brain tumor, or any other condition that raises the pressure inside of your skull. The likelihood that you will experience breathing issues may increase if you are an older adult, weak, or undernourished as a result of a sickness. Get emergency medical care if you encounter any of the following symptoms, or call your doctor right away: sluggish breathing, protracted breath gaps, or shortness of breath.

The use of codeine-containing medications in children has been linked to serious and fatal breathing issues, including deaths and slow or difficult breathing. Acetaminophen with codeine should never be used to children under the age of 12 for the treatment of pain or cough, or to children under the age of 18 for the relief of pain following surgery to remove the tonsils and/or adenoids. Children aged 12 to 18 who are obese or have a neuromuscular disease (a condition that affects the nerves that control voluntary muscles) shouldn’t be given acetaminophen or codeine, in order to reduce their chance of breathing issues, they should not smoke, have a lung illness, or have obstructive sleep apnea (a condition in which the airway narrows or becomes clogged and breathing stops briefly during sleep).

The combination medication’s active ingredient, acetaminophen, when used in excess can harm the liver, sometimes seriously enough to necessitate liver transplantation or even result in death. If you don’t carefully read the instructions on the prescription or package label, or if you use multiple acetaminophen-containing products, you risk mistakenly taking too much of the medication. Be advised that you shouldn’t take more acetaminophen than 4,000 mg per day. If you have liver illness now or ever had it, let your doctor know. It could be challenging for you to figure out how much acetaminophen you are taking overall if you need to use multiple acetaminophen-containing products. Obtain assistance from your physician or pharmacist.

Taking certain medications during your treatment with acetaminophen and codeine may increase the risk that you will experience breathing problems or other serious, life threatening breathing problems, sedation, or coma. Tell your doctor if you are taking or plan to take any of the following medications: certain antifungal medications including itraconazole (Onmel, Sporanox), ketoconazole, and voriconazole (Vfend); benzodiazepines such as alprazolam (Xanax), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), and triazolam (Halcion); carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril); erythromycin (Erytab, Erythrocin); certain medications for human immunodeficiency virus (HIV) including indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); muscle relaxants; other pain medications; phenytoin (Dilantin, Phenytek); rifampin (Rifadin, Rimactane, in Rifamate); sedatives; sleeping pills; or tranquilizers. Your doctor may need to change the dosages of your medications and will monitor you carefully. If you take acetaminophen and codeine with any of these medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.

You have a higher risk of developing severe, perhaps fatal adverse effects while receiving acetaminophen and codeine treatment if you consume alcohol, use prescription or over-the-counter treatments that include alcohol, or use illicit substances. During your treatment, refrain from drinking alcohol, taking alcohol-containing prescription or over-the-counter medications, or using illegal substances.

If you are pregnant or want to become pregnant, let your doctor know. Regular use of acetaminophen and codeine during pregnancy increases the risk that your unborn child could develop potentially fatal withdrawal symptoms. If your infant exhibits any of the following symptoms, contact your doctor straight away: irritability, hyperactivity, disturbed sleep, high-pitched crying, excessive shaking of a body part, vomiting, diarrhea, or failure to gain weight.

When you start treatment with acetaminophen and codeine as well as each time your prescription is filled, your doctor or pharmacist will provide you the manufacturer’s patient information sheet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

Why is this medication prescribed?

Acetaminophen and codeine are combined to treat mild to moderate pain. The drug acetaminophen belongs to the group of drugs known as analgesics (painkillers) and antipyretics (fever reducers). It functions by cooling the body and altering how the body perceives pain. In addition to being an antitussive, codeine is a member of the opiate (narcotic) analgesic drug class. The way the brain and nervous system react to pain is altered when codeine is used to relieve pain. Codeine serves to lessen coughing by reducing activity in the area of the brain that triggers coughing.

How should this medicine be used?

The oral dosage forms for the acetaminophen and codeine mixture are tablets, capsules, and liquids. As needed, it is typically taken every four hours. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Take codeine and acetaminophen precisely as prescribed.

Do not discontinue taking acetaminophen and codeine without consulting your doctor if you have been taking it for several weeks or longer. Your dose could be gradually reduced by your doctor. Acetaminophen and codeine withdrawal symptoms may include agitation, teary eyes, widened pupils (black circles in the center of the eyes), irritability, anxiety, runny nose, trouble falling or staying asleep, yawning, sweating, rapid breathing, rapid heartbeat, chills, nausea, loss of appetite, vomiting, diarrhea, stomach cramps, or muscle aches if you suddenly stop taking them.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking acetaminophen and codeine,

  • If you have any allergies, including to acetaminophen, codeine, sulfite, other drugs, or any of the substances in acetaminophen and codeine products, inform your doctor and pharmacist right away. For a list of the ingredients, ask your doctor or pharmacist.
  • Any of the following monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate), should be mentioned to your doctor or pharmacist. If you are currently taking one or more of these medications, or if you have recently taken them, your doctor probably won’t advise you to take acetaminophen plus codeine.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter medications, vitamins, herbal items, nutritional supplements, and any drugs you are now taking or intend to take. If you’re taking any of the following, be sure to mention it: antihistamines (used in treatments for colds and allergies); amiodarone (Nexterone, Pacerone); butorphanol, bupropion (Aplenzin, Wellbutrin, Zyban), buprenorphine (Belbuca, Butrans, Probuphine), and diuretics (water tablets); almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, in Treximet), and zolmitriptan (Zomig) are among the migraine treatments; citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft) are examples of selective serotonin-reuptake inhibitors; nalbuphine; pentazocine (Talwin); tramadol (Conzip), trazodone (Oleptro), desvenlafaxine (Khedezla, Pristiq), milnacipran (Savella), and venlafaxine (Effexor) are examples of serotonin and norepinephrine reuptake inhibitors. amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil) are examples of tricyclic antidepressants (sometimes known as “mood elevators”). Acetaminophen and codeine may also interact with many other drugs, so be sure to let your doctor know about all the drugs you’re taking even those that aren’t on this list. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • If you have a blockage or constriction of your stomach or intestines, paralytic ileus (condition where digested food does not flow through the intestines), any of the conditions listed in the IMPORTANT WARNING section, or any of the other conditions, let your doctor know. If you suffer from any of these problems, your doctor might advise against taking acetaminophen and codeine.
  • Inform your doctor if you suffer from or have ever suffered from kidney, pancreatic, gallbladder, or seizure disorders.
  • You should be aware that this medicine may lower both male and female fertility. Discuss the dangers of taking acetaminophen and codeine with your doctor.
  • Describe to your doctor if you are nursing a baby. While using codeine and acetaminophen, you shouldn’t breastfeed. Codeine can result in shallow breathing, noisy breathing, disorientation, excessive drowsiness, nursing difficulties, and limpness in breastfed newborns.
  • Inform the surgeon or dentist that you are taking acetaminophen and codeine if you are having surgery, including dental surgery.
  • You should be aware that this medicine may cause you to feel sleepy. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
  • You should be aware that taking acetaminophen and codeine together may increase your risk of fainting if you stand up too rapidly from a laying position. To avoid this issue, slowly get out of bed and sit up after a few minutes of resting your feet on the floor.

What should I do if I forget a dose?

Typically, this drug is given as needed. Take the missing dose as soon as you remember it if your doctor has instructed you to take acetaminophen and codeine on a regular basis. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Codeine with acetaminophen could have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Constipation
  • Having trouble urinating

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical assistance if you develop any of these signs or any of the ones listed in the IMPORTANT WARNING section:

  • Nausea, vomiting, weight loss, anorexia, or lightheadedness
  • Agitation, hallucinations (hearing voices or seeing things that are not there), disorientation, fever, sweating, shivering, extremely stiff or twitching muscles, loss of coordination, nausea, vomiting, or diarrhea
  • Blistering, peeling, or red skin
  • Rash
  • Hives
  • Itching
  • Edema of the hands, feet, ankles, lower legs, cheeks, neck, tongue, lips, and eyes
  • Hoarseness
  • Breathing or swallowing challenges
  • Failure to achieve or maintain erection
  • Irregular periods of time
  • Less sexual arousal

Other adverse effects could be brought on by acetaminophen and codeine. If you have any strange side effects while taking this medicine, contact your doctor right once.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online at or by phone at 1-800-332-1088 if you have a serious side event.

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Keep it at room temperature and out of the bathroom and other places with excessive heat and moisture.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilizing a medicine take-back program is the easiest approach to get rid of your medication. To find out about take-back programs in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back program, see the FDA’s Safe Disposal of Medicines website at for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

You should speak with your doctor about keeping naloxone, a life-saving drug, accessible while taking acetaminophen and codeine (e.g., at home or the workplace). Naloxone is used to undo an overdose’s potentially fatal consequences. To treat harmful symptoms brought on by excessive levels of opiates in the blood, it functions by inhibiting the effects of opiates. If you live with young children or someone who has abused prescription or illicit drugs, your doctor could also advise you to get naloxone. Make sure you, your family, your caretakers, and anyone else who spends time with you are aware of the signs of an overdose, how to administer naloxone, and what to do until emergency assistance arrives. You and your family members will be shown how to use the medication by your doctor or pharmacist. For the directions, speak to your pharmacist or go to the manufacturer’s website. If you start to experience overdose symptoms, a friend or family member should administer the first dose of naloxone, contact 911 right away, and stay by your side while keeping a careful eye on you until emergency medical assistance comes. After receiving naloxone, your symptoms can come back a short while later. The person should administer you another dose of naloxone if your symptoms come back. If symptoms reappear before receiving medical attention, more doses may be given every 2 to 3 minutes.

Get medical assistance right away if someone takes more acetaminophen and codeine than is advised, even if they are symptom-free. Overdose signs could include the following:

  • Nausea
  • Vomiting
  • Reduced appetite
  • Sweating
  • Uncommon bruising or bleeding
  • Stomach’s upper right corner hurts
  • Yellowing of the eyes or skin
  • Weak or sluggish breathing
  • Having trouble breathing
  • Sleepiness
  • Not able to speak or awaken
  • Decline in muscular tone
  • Expanded or narrowed pupils
  • Clammy, frigid skin
  • Fainting
  • Sluggish heartbeat

What other information should I know?

Keep all of your doctor’s appointments. To determine how well your body responds to acetaminophen and codeine, your doctor may request specific lab tests.

Inform your doctor and the lab staff that you are taking acetaminophen and codeine prior to any laboratory test (particularly those that use methylene blue).

No one else should take your medication. Codeine and acetaminophen are considered restricted substances. Only a limited amount of refills are permitted for prescriptions; if you have any doubts, speak with your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Capital® & Codeine
  • Codrix®
  • Empracet® (#3, #4)
  • Papa-deine® (#3, #4)
  • Phenaphen® with Codeine (#2, #3, #4)
  • Proval® #3
  • Tylenol® with Codeine (#3, #4)
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