Phrenilin with Caffeine and Codeine (Oral)

Butalbital, acetaminophen, caffeine, and codeine combination is used to relieve tension (or muscle contraction) headaches. It is not recommended to use this product for a long time or repeatedly.

Butalbital is part of a group of medicines called barbiturates. They work in the central nervous system (CNS) to produce their effects.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not cause dependence when taken for a long time. However, taking large doses of acetaminophen can lead to unwanted effects, including serious liver damage. Although rare, there have been reports of acetaminophen leading to liver transplantation and death, usually when taken in high doses or when using multiple products that contain acetaminophen.

Caffeine is a CNS stimulant that is used with pain relievers to enhance their effect. It is also used for migraine headaches. Codeine is part of a group of medicines called narcotic analgesics (pain medicines). It works on the central nervous system (CNS) to relieve pain.

Using butalbital or codeine for a long time or in large doses can lead to habit formation, resulting in mental or physical dependence. However, people with ongoing pain should not let the fear of dependence prevent them from using narcotics to manage their pain. Mental dependence (addiction) is unlikely to occur when narcotics or barbiturates are used for this reason. Physical dependence may cause withdrawal side effects if you suddenly stop taking the medicine. In patients who experience headaches, the first sign of withdrawal may be new (rebound) headaches.

This medicine is available only through a restricted distribution program known as the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

It is very important for your doctor to monitor your progress while you are using this medicine, especially in the first 24 to 72 hours of treatment. This helps your doctor determine if the medicine is effective and if you should keep taking it. Blood and urine tests may be needed to check for side effects.

Do not use this medicine if you are currently taking or have taken an MAO inhibitor (MAOI) such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®] in the past 14 days.

If you think you or someone else may have taken an overdose of this medicine, seek emergency help immediately. Your doctor may also administer naloxone and other treatments for an overdose. Signs of an overdose include: dark urine, difficulty or trouble breathing, irregular, fast or slow, or shallow breathing, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils in the eyes, or yellowing of the eyes or skin.

This medicine may cause breathing problems while sleeping (e.g., sleep apnea, sleep-related hypoxemia). Your doctor may lower your dose if you experience sleep apnea (pauses in breathing during sleep) while using this medicine.

This medicine will enhance the effects of alcohol and other CNS depressants (medicines that can cause drowsiness or decreased alertness). Some examples of CNS depressants include antihistamines or allergy or cold medicines, sedatives, tranquilizers, or sleeping pills, other prescription pain medications or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. There is also a higher risk of liver damage if you consume 3 or more alcoholic drinks while taking acetaminophen. Do not drink alcoholic beverages, and consult your doctor before taking any of these medications while using this medicine.

This medicine may lead to problems with your adrenal glands. Contact your doctor right away if you notice darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Dizziness, lightheadedness, or fainting may occur when you stand up suddenly from lying down or sitting. Getting up slowly may help. Additionally, lying down for a time may ease dizziness or lightheadedness. If this issue persists or worsens, consult your doctor immediately.

This medicine may cause you to feel dizzy, drowsy, confused, or disoriented. Do not drive or perform any tasks that could be dangerous until you know how this medicine affects you.

Contact your doctor right away if you experience pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellowing of the eyes or skin. These could be signs of a serious liver issue.

This medicine may cause severe skin reactions (e.g., acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis). Contact your doctor immediately if you develop blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and needs immediate medical attention. Call your doctor right away if you have a cough, dizziness, rapid heartbeat, hives, rash, itching, swelling of the eyelids or around the eyes, face, lips, or tongue, tightness in the chest, trouble breathing or swallowing, or unusual tiredness or weakness while using this medicine.

Check the labels of all nonprescription (over-the-counter [OTC]) or prescription medications you are currently taking. If any contain a barbiturate, acetaminophen, caffeine, or codeine, consult your doctor. Taking them together with this medicine may lead to an overdose.

Using this medicine during pregnancy may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn. Inform your doctor right away if you think you are pregnant or plan to become pregnant while using this medicine.

Codeine is converted to morphine in the body. Some people convert codeine to morphine more rapidly than others. These individuals are known as "ultra-rapid metabolizers of codeine." Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that there is too much morphine in the body, leading to more side effects than usual. Children may be particularly sensitive to this effect. Do not give this medicine to:

• Children younger than 12 years of age.
• Children younger than 18 years of age who have had surgery to remove tonsils or adenoids.
• Children 12 to 18 years of age who are at high risk for breathing problems (e.g., obstructive sleep apnea, obesity, lung disease).

If a nursing mother is an ultra-rapid metabolizer of codeine, it could result in a morphine overdose in the nursing baby, causing very serious side effects.

For nursing mothers taking this medicine:

• Discuss with your doctor if you have any questions about taking codeine or how this medicine may affect your baby.
• Call your doctor if you become extremely tired and find it hard to care for your baby.
• Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
• Seek immediate medical attention if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, trouble breathing, or limpness. These may indicate an overdose and require urgent care.

Do not stop taking this medicine suddenly without first consulting your doctor. Your doctor may want you to gradually reduce the dosage before stopping completely to help prevent a worsening of your condition and minimize withdrawal symptoms such as restlessness, chills, muscle pain, runny nose, sweating, tearing of the eyes, or yawning.

This medicine may be habit-forming. If you feel that it is not working as effectively, do not exceed your prescribed dose. Contact your doctor for guidance.

Using narcotics for a long time can lead to severe constipation. To prevent this, your doctor may recommend laxatives, increased fluid intake, or more fiber in your diet. Be sure to follow these instructions carefully, as ongoing constipation can lead to more serious issues.

Before having any medical tests, inform the medical doctor conducting the tests that you are taking this medicine. The results of some tests may be influenced by this medicine.

Before undergoing any type of surgery (including dental surgery) or emergency treatment, let the medical doctor or dentist know that you are taking this medicine. Serious side effects can happen if your doctor or dentist administers certain medications without being aware that you have been taking butalbital or codeine.

Contact your doctor right away if you experience anxiety, restlessness, a rapid heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or hallucinations. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you are also taking certain other medications that affect serotonin levels in your body.

Using too much of this medicine may lead to infertility (inability to have children). Speak with your doctor before using this medicine if you plan to have children.

Do not take other medications unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the chances of using the medication must be weighed against the good it will do. This is a decision you and your doctor will make. For this drug, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this drug or any other medications. As well tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of butalbital, acetaminophen, caffeine, and codeine combination in the pediatric population. It should not be used in children younger than 12 years of age. Safety and efficacy have not been established.

This medication should not be used to ease pain following surgery removal of tonsils or adenoids in any children. Serious breathing issues and deaths have been reported in some children who received codeine following tonsil or adenoid surgery.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of butalbital, acetaminophen, caffeine, and codeine combination in the elderly. Nevertheless, elderly patients are more likely to have age-related liver, kidney, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medicine should be prescribed or you should stop breastfeeding while using this medication.

Interactions with Medications

Although certain medications should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this drug, it is especially essential that your healthcare professional know if you are using any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this drug with any of the following medicines is not recommended. Your clinician may decide not to treat you with this drug or change some of the other medicines you take.

• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nalmefene
• Naltrexone
• Nialamide
• Ozanimod
• Phenelzine
• Procarbazine
• Rasagiline
• Riociguat
• Safinamide
• Samidorphan
• Selegiline
• Toloxatone
• Tranylcypromine
• Viloxazine

Using this medication with any of the following drugs is typically not advised, but may be required in some cases. If both medicines are prescribed together, your physician may change the dose or how often you use one or both of the medicines.

• Abametapir
• Abiraterone Acetate
• Acepromazine
• Aclidinium
• Alfentanil
• Almotriptan
• Alosetron
• Alprazolam
• Amantadine
• Amifampridine
• Amiloride
• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Amprenavir
• Anileridine
• Anisindione
• Apalutamide
• Aprepitant
• Aprobarbital
• Aripiprazole
• Aripiprazole Lauroxil
• Armodafinil
• Asenapine
• Atazanavir
• Atropine
• Baclofen
• Barbital
• Belladonna
• Bemetizide
• Bendroflumethiazide
• Benperidol
• Bentazepam
• Benzhydrocodone
• Benzphetamine
• Benzthiazide
• Benztropine
• Biperiden
• Boceprevir
• Bosentan
• Bromazepam
• Bromopride
• Brompheniramine
• Bumetanide
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Canrenoate
• Canrenone
• Capmatinib
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Cenobamate
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorothiazide
• Chlorpheniramine
• Chlorpromazine
• Chlorthalidone
• Chlorzoxazone
• Cimetidine
• Cinacalcet
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clemastine
• Clidinium
• Clobazam
• Clomipramine
• Clonazepam
• Clopamide
• Clopidogrel
• Clorazepate
• Cloxazolam
• Clozapine
• Cobicistat
• Cocaine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclopenthiazide
• Cyclopentolate
• Cyclosporine
• Cyclothiazide
• Cyproheptadine
• Dantrolene
• Daridorexant
• Darifenacin
• Darunavir
• Delavirdine
• Delorazepam
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diacetylmorphine
• Diazepam
• Diazoxide
• Dibenzepin
• Dichloralphenazone
• Dicumarol
• Dicyclomine
• Difenoxin
• Dihydrocodeine
• Diltiazem
• Dimenhydrinate
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Doxylamine
• Dronedarone
• Droperidol
• Drospirenone
• Duloxetine
• Efavirenz
• Elagolix
• Eletriptan
• Enflurane
• Enzalutamide
• Eplerenone
• Erythromycin
• Escitalopram
• Esketamine
• Eslicarbazepine Acetate
• Estazolam
• Eszopiclone
• Eterobarb
• Ethacrynic Acid
• Ethchlorvynol
• Ethinyl Estradiol
• Ethopropazine
• Ethylmorphine
• Etonogestrel
• Etozolin
• Etravirine
• Fedratinib
• Fenfluramine
• Fentanyl
• Fesoterodine
• Fexinidazole
• Flavoxate
• Flibanserin
• Fluconazole
• Flunitrazepam
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Frovatriptan
• Furosemide
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Givosiran
• Glycopyrrolate
• Glycopyrronium Tosylate
• Granisetron
• Halazepam
• Haloperidol
• Halothane
• Heptabarbital
• Hexobarbital
• Homatropine
• Hydrochlorothiazide
• Hydrocodone
• Hydroflumethiazide
• Hydromorphone
• Hydroxytryptophan
• Hydroxyzine
• Hyoscyamine
• Idelalisib
• Imatinib
• Imipramine
• Indapamide
• Indinavir
• Iobenguane I 131
• Ipratropium
• Isocarboxazid
• Isoflurane
• Isoniazid
• Itraconazole
• Ivacaftor
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Lacosamide
• Larotrectinib
• Lasmiditan
• Lemborexant
• Lenacapavir
• Letermovir
• Levocetirizine
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lomitapide
• Lopinavir
• Loprazolam
• Lorazepam
• Lorcaserin
• Lorlatinib
• Lormetazepam
• Loxapine
• Lumacaftor
• Magnesium Oxybate
• Mavacamten
• Meclizine
• Medazepam
• Melitracen
• Melperone
• Mepenzolate
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaclazepam
• Metaxalone
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methyclothiazide
• Methylene Blue
• Metoclopramide
• Metolazone
• Mibefradil
• Midazolam
• Mifepristone
• Milnacipran
• Mirabegron
• Mirtazapine
• Mitotane
• Modafinil
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nafcillin
• Nalbuphine
• Naratriptan
• Nefazodone
• Nelfinavir
• Netupitant
• Nevirapine
• Nicomorphine
• Nifedipine
• Nilotinib
• Nitrazepam
• Nitrous Oxide
• Nordazepam
• Norethindrone
• Norgestimate
• Norgestrel
• Nortriptyline
• Olanzapine
• Omaveloxolone
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxcarbazepine
• Oxitropium Bromide
• Oxybutynin
• Oxycodone
• Oxymorphone
• Ozanimod
• Palbociclib
• Palonosetron
• Papaveretum
• Paregoric
• Paroxetine
• Peginterferon Alfa-2b
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenelzine
• Phenindione
• Phenobarbital
• Phenprocoumon
• Phenytoin
• Pinazepam
• Pipenzolate Bromide
• Piperacetazine
• Piperaquine
• Pipotiazine
• Pirenzepine
• Piretanide
• Piritramide
• Pixantrone
• Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
• Polythiazide
• Posaconazole
• Potassium Oxybate
• Prazepam
• Prednisone
• Pregabalin
• Primidone
• Procarbazine
• Prochlorperazine
• Procyclidine
• Promazine
• Promethazine
• Propantheline
• Propiverine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Quinethazone
• Quinidine
• Quinine
• Ramelteon
• Ranitidine
• Ranolazine
• Rasagiline
• Remifentanil
• Remimazolam
• Remoxipride
• Rifabutin
• Rifampin
• Rifapentine
• Ritlecitinib
• Ritonavir
• Rizatriptan
• Rolapitant
• Ropeginterferon Alfa-2b-njft
• Safinamide
• Saquinavir
• Scopolamine
• Secobarbital
• Selegiline
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• Solifenacin
• Spironolactone
• St John's Wort
• Stramonium
• Sufentanil
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Telaprevir
• Telithromycin
• Temazepam
• Terbinafine
• Terodiline
• Tetrazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Thiothixene
• Tianeptine
• Tilidine
• Tiotropium
• Tizanidine
• Tocilizumab
• Tolonium Chloride
• Tolterodine
• Topiramate
• Torsemide
• Tramadol
• Tranylcypromine
• Trazodone
• Triamterene
• Triazolam
• Trichlormethiazide
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trihexyphenidyl
• Trimeprazine
• Trimipramine
• Tropicamide
• Trospium
• Tryptophan
• Ulipristal
• Umeclidinium
• Venlafaxine
• Verapamil
• Vilazodone
• Voriconazole
• Vortioxetine
• Voxelotor
• Xipamide
• Zaleplon
• Ziprasidone
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

Using this medicine with any of the following medications may cause an increased chance of certain side effects, but using both drugs may be the best therapy for you. If both drugs are prescribed together, your clinician may change the dose or how often you use one or both of the drugs.

• Acenocoumarol
• Carbamazepine
• Fosphenytoin
• Lixisenatide
• Ospemifene
• Phenytoin
• Prednisone
• St John's Wort
• Warfarin
• Zidovudine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may additionally cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not advised, but may be unavoidable in some cases. If used together, your clinician may change the dose or how often you use this drug, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Tobacco

Using this medication with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how frequently you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cabbage
• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you inform your clinician if you have any other medical issues, especially:

• Addison's disease (an adrenal problem) or
• Alcohol or drug abuse or dependence, or history of or
• Brain problems (eg, tumor, increased intracranial pressure) or
• Breathing or lung issues (eg, COPD, hypercapnia, hypoxia, sleep apnea) or
• Cor pulmonale (severe heart condition) or
• Depression, or history of or
• Enlarged prostate or
• Head injury, history of or
• Hypothyroidism (underactive thyroid) or
• Obesity (overweight) or
• Trouble urinating or
• Weakened physical condition—Use with caution. May increase risk for more serious side effects.

• Gallbladder issues or
• Hypotension (low blood pressure) or
• Pancreatitis (swelling of the pancreas) or
• Seizures, or history of—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased since of slower removal of the medication from the body.

• Lung or breathing issues (eg, asthma, respiratory depression), serious or
• Porphyria (enzyme problem) or
• Stomach or bowel blockage (including paralytic ileus) or
• Surgery (eg, nasopharyngeal tonsils, tonsils)—Should not be used in patients with these conditions.

Along with its necessary effects, this medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects occur:

Less common

• Mild confusion
• Mental depression
• Mild unusual excitement

Rare

• Bleeding or crusting sores on the lips
• Chest pain or tightness
• Fever with or without chills
• Hive-like swellings on the eyelids, face, lips, or tongue
• Hives, itching, or skin rash
• Muscle cramps or pain
• Red, thickened, or scaly skin
• Seeing, hearing, or feeling things that are not there
• Seizures
• Sore throat
• Sores, ulcers, or white spots in the mouth
• Swollen or painful glands
• Trouble breathing

Incidence not known

• Agitation
• Cough
• Darkening of the skin
• Diarrhea
• Difficulty swallowing
• Dizziness
• Fainting
• Fever
• Loss of appetite
• Nausea
• Overactive reflexes
• Poor coordination
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Restlessness
• Shivering
• Talking or acting with excitement you cannot control
• Trembling or shaking
• Twitching
• Unusual tiredness or weakness
• Vomiting

Get emergency help immediately if any of the following overdose symptoms occur:

Symptoms of overdose

• Severe anxiety
• Cold and clammy skin
• Severe confusion
• Severe dizziness, lightheadedness, drowsiness, or weakness
• Severe excitement
• Increased sleepiness in babies (more than usual)
• Increased sweating
• Severe irritability
• Limpness (in babies)
• Nausea
• Severe restlessness
• Slow, fast, or irregular heartbeat
• Slurred speech
• Stomach cramps or pain
• Swelling, pain, or tenderness in the upper abdomen or stomach area
• Trembling or shaking of the hands or feet
• Severe trouble sleeping
• Unusually slow breathing
• Vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome, or if you have any questions about them:

More common

• Bloated or "gassy" feeling
• Mild drowsiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Fioricet with Codeine
• Phrenilin with Caffeine and Codeine

Available Dosage Forms:

• Capsule

Therapeutic Class: Opioid/Barbiturate Combination

Pharmacologic Class: Barbiturate

Chemical Class: Methylxanthine

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken for a long time, it may become habit-forming and cause mental or physical dependence. Also, large amounts of acetaminophen may cause liver damage if taken for a long time.

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of butalbital, acetaminophen, caffeine, and codeine combination. This medicine should also come with a Medication Guide. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours), as this may increase the risk for serious liver problems.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

This medicine will relieve a headache best if you take it as soon as the headache begins. If you get warning signs of a migraine, take this medicine as soon as you are sure that the migraine is coming. This may even stop the headache pain from occurring. Lying down in a quiet, dark room for a while after taking the medicine also helps to relieve headaches.

People who get a lot of headaches may need to take a different medicine to help prevent headaches. It is important that you follow your doctor's directions about taking other medicines, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve than before. This will reduce the amount of headache relievers that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules): For tension headaches: Adults—1 or 2 capsules every 4 hours as needed. However, the dose is usually not more than 6 capsules per day. Do not exceed 4 grams (4000 milligrams) of acetaminophen (Tylenol®) per day. Children 12 years of age and older—Use and dose must be determined by your doctor. Children younger than 12 years of age—Should not be used in these patients.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm.