Maxidone (Oral)

Hydrocodone and acetaminophen combination is used to relieve pain that is severe enough to need opioid treatment, especially when other pain medicines have not worked well enough or cannot be tolerated.

Acetaminophen is used to relieve pain and lower fever in patients. It does not become habit-forming when taken for a long time. However, taking large doses of acetaminophen may cause unwanted effects, including liver damage.

Hydrocodone is part of a group of medicines called narcotic analgesics (pain medicines). It works on the central nervous system (CNS) to relieve pain and can stop or prevent cough.

When hydrocodone is used for a long time, it may become habit-forming, leading to mental or physical dependence. However, people with ongoing pain should not let the fear of dependence prevent them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to happen when narcotics are used for this reason. Physical dependence may cause withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be avoided by gradually lowering the dose over time before stopping treatment completely.

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

It is very important for your doctor to monitor your or your child's progress while using this medicine, especially during the first 24 to 72 hours of treatment. This helps your doctor determine if the medicine is effective and if you or your child should continue 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 (e.g., isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) in the past 14 days.

It is illegal and dangerous for anyone else to use your medicine. Keep your unused tablets in a safe and secure location. People who are addicted to drugs may try to steal this medicine.

This medicine will increase the effects of alcohol and other CNS depressants (medications that can make you sleepy or less alert). Some examples of CNS depressants include antihistamines or allergy/cold medicines, sedatives, tranquilizers, or sleeping pills, other prescription pain medications or narcotics, seizure medications or barbiturates, muscle relaxants, or anesthetics (numbing drugs), including some dental anesthetics. Additionally, drinking three or more alcoholic beverages while taking acetaminophen may increase the risk of liver damage. Do not drink alcohol, and consult your doctor before taking any of these medications while using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not as effective, do not take more than your prescribed dose.

If you suspect that you or someone else has taken an overdose of this medicine, seek emergency help immediately. Your doctor may also give naloxone to treat an overdose. Signs of an overdose include: cold, clammy skin, coughing that may produce a pink frothy sputum, dark urine, difficulty or trouble breathing, irregular, fast or slow, or shallow breathing, nausea, vomiting, upper stomach pain, pale or blue lips, fingernails, or skin, pinpoint pupils, or yellowing of the eyes or skin.

This medicine may cause sleep-related breathing issues (e.g., sleep apnea, sleep-related hypoxemia). Your doctor may reduce your dose if you have sleep apnea (a condition where you temporarily stop breathing during sleep) while using this medicine.

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

Contact your doctor immediately if you have upper stomach pain or tenderness, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellowing of your eyes or skin. These could be signs of a serious liver issue.

This medicine may lead to serious skin reactions (e.g., acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis). Contact your doctor right away if you experience 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 trigger a serious allergic reaction known as anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, difficulty breathing, trouble swallowing, or any swelling of your hands, face, or mouth while using this medicine.

Dizziness, lightheadedness, or fainting may happen when you stand up suddenly from a lying or sitting position. Getting up slowly may help reduce this issue. Also, lying down for a while may relieve dizziness or lightheadedness.

This medicine may cause dizziness, drowsiness, or lightheadedness. Do not drive or engage in activities that could be dangerous until you know how this medicine affects you.

Using narcotics for a long time can lead to severe constipation. To prevent this, your doctor may recommend that you or your child take laxatives, drink plenty of fluids, or increase fiber in your diet. Be sure to follow these instructions carefully, as ongoing constipation can result in more serious issues.

Before you or your child undergo any medical tests, inform the medical doctor in charge that you are taking this medicine. The results of some tests may be influenced by this medicine.

Do not change your dose or suddenly stop using this medicine without first consulting your doctor. Your doctor may want you or your child to gradually reduce the amount used before stopping completely. This can help prevent worsening of your condition and reduce the risk of withdrawal symptoms, including stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.

Using this medicine while pregnant may cause serious side effects, including neonatal withdrawal syndrome in your newborn. Inform your doctor immediately if your child exhibits abnormal sleep patterns, diarrhea, a high-pitched cry, irritability, shakiness or tremors, sneezing, weight loss, vomiting, yawning, or failure to gain weight. Consult your doctor right away if you think you are pregnant or plan to become pregnant while using this medicine.

Contact your doctor right away if you experience anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or hallucinations. These may indicate a serious condition called serotonin syndrome. Your risk may increase 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 (the inability to have children). Speak with your doctor before using this medicine if you plan to have children.

Do not take any other medicines unless they have been discussed with your doctor. This includes prescription or over-the-counter (OTC) medicines and herbal or vitamin supplements.

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

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medication or any other medicines. Also 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 hydrocodone and acetaminophen combination capsules and tablets in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocodone and acetaminophen combination oral solution in children 2 years of age and older. Nevertheless, safety and efficacy have not been established in children younger than 2 years of age.

Geriatric

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

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential chances before using this drug while breastfeeding.

Interactions with Medicines

Although certain medicines 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 using this medicine, it is especially important that your healthcare professional know if you are using any of the medications 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 advised. Your doctor may decide not to treat you with this medication or change some of the other drugs you take.

• Nalmefene
• Naltrexone
• Safinamide
• Samidorphan

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

• Abametapir
• Acepromazine
• Alfentanil
• Almotriptan
• Alprazolam
• Amifampridine
• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Amprenavir
• Anileridine
• Aprepitant
• Aripiprazole
• Armodafinil
• Asenapine
• Atazanavir
• Baclofen
• Benperidol
• Benzphetamine
• Boceprevir
• Bosentan
• Bromazepam
• Bromopride
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Ceritinib
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clomipramine
• Clonazepam
• Clopidogrel
• Clorazepate
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclosporine
• Daridorexant
• Darunavir
• Dasabuvir
• Delavirdine
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diazepam
• Dibenzepin
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diltiazem
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Doxylamine
• Dronedarone
• Droperidol
• Duloxetine
• Efavirenz
• Eletriptan
• Enflurane
• Enzalutamide
• Erythromycin
• Escitalopram
• Esketamine
• Eslicarbazepine Acetate
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Etravirine
• Fedratinib
• Fenfluramine
• Fentanyl
• Fexinidazole
• Flibanserin
• Fluconazole
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Frovatriptan
• Furazolidone
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Granisetron
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydromorphone
• Hydroxytryptophan
• Hydroxyzine
• Idelalisib
• Imatinib
• Imipramine
• Indinavir
• Iproniazid
• Isocarboxazid
• Isoflurane
• Isoniazid
• Itraconazole
• Ivacaftor
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Lacosamide
• Lasmiditan
• Lemborexant
• Lenacapavir
• Levocetirizine
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lomitapide
• Lopinavir
• Lorazepam
• Lorcaserin
• Loxapine
• Lumacaftor
• Magnesium Oxybate
• Mavacamten
• Meclizine
• Melitracen
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Metoclopramide
• Mibefradil
• Midazolam
• Mifepristone
• Milnacipran
• Mirtazapine
• Mitotane
• Moclobemide
• Modafinil
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nafcillin
• Nalbuphine
• Naratriptan
• Nefazodone
• Nelfinavir
• Netupitant
• Nevirapine
• Nialamide
• Nicomorphine
• Nilotinib
• Nitrazepam
• Nitrous Oxide
• Nortriptyline
• Olanzapine
• Omaveloxolone
• Ombitasvir
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxcarbazepine
• Oxycodone
• Oxymorphone
• Ozanimod
• Palbociclib
• Palonosetron
• Papaveretum
• Paregoric
• Paritaprevir
• Paroxetine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenelzine
• Phenobarbital
• Phenytoin
• Piperacetazine
• Pipotiazine
• Piritramide
• Pixantrone
• Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
• Posaconazole
• Potassium Oxybate
• Prazepam
• Prednisone
• Pregabalin
• Primidone
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Ramelteon
• Ranitidine
• Ranolazine
• Rasagiline
• Remifentanil
• Remimazolam
• Remoxipride
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Rizatriptan
• Ropeginterferon Alfa-2b-njft
• Saquinavir
• Scopolamine
• Secobarbital
• Selegiline
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• St John's Wort
• Sufentanil
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Telaprevir
• Telithromycin
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tianeptine
• Tilidine
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Tranylcypromine
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Trimipramine
• Tryptophan
• Venlafaxine
• Verapamil
• Vilazodone
• Voriconazole
• Vortioxetine
• Zaleplon
• Ziprasidone
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

Using this drug with any of the following drugs may cause an increased chance of certain adverse effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your physician may change the dose or how frequently you use one or both of the medicines.

• Acenocoumarol
• Carbamazepine
• Fosphenytoin
• Lixisenatide
• Phenytoin
• 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 medication with any of the following is typically not advised, but may be unavoidable in some cases. If used together, your clinician may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Grapefruit Juice
• Tobacco

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

• Cabbage

Other Medical Issues

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

• Addison's disease (adrenal gland issue) or
• Alcohol abuse, history of or
• Brain tumor, or history of or
• Breathing or lung issues (eg, asthma, apnea, COPD, emphysema, hypoxia) or
• Cor pulmonale (severe heart condition) or
• CNS depression or
• Drug dependence, especially narcotic abuse or dependence, or history of or
• Enlarged prostate (BPH, prostatic hypertrophy) or
• Head injuries, or history of or
• Increased pressure in the head or
• Hypothyroidism (an underactive thyroid) or
• Problems with passing urine—Use with caution. May raise chance for more severe adverse effects.

• Asthma, acute or serious or
• Respiratory depression (severe breathing issue) or
• Stomach or bowel blockage (eg, paralytic ileus), known or suspected—Should not be used in patients with these conditions.

• Hypotension (low blood pressure) or
• Pancreatitis (swelling of the pancreas) or
• Seizures, 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 medicine from the body.

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

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

More common

• Dizziness
• Lightheadedness

Incidence not known

• Agitation
• Pain in the back, legs, or stomach
• Black, tarry stools
• Bleeding gums
• Blistering, peeling, or loosening of the skin
• Blood in urine or stools
• Blood in vomit
• Bluish lips or skin
• Chills
• Choking
• Confusion
• Cough
• Dark urine
• Darkening of the skin
• Decrease in how often you urinate
• Decrease in urine volume
• Diarrhea
• Difficulty or trouble breathing
• Difficulty passing urine (dribbling)
• Difficulty swallowing
• Fainting
• Fast heartbeat
• Fever
• Fever with or without chills
• General body swelling
• General feeling of tiredness or weakness
• Headache
• Hoarseness
• Irregular, fast, slow, or shallow breathing
• Joint or muscle pain
• Light-colored stools
• Loss of appetite
• Lower back or side pain
• Mental depression
• Nausea
• Nosebleeds
• Not breathing
• Overactive reflexes
• Painful or difficult urination
• Pale or blue lips, fingernails, or skin
• Pinpoint red spots on the skin
• Poor coordination
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Red irritated eyes
• Red skin lesions, often with a purple center
• Restlessness
• Severe or continuing stomach pain
• Shivering
• Skin rash, hives, or itching
• Sore throat
• Sore tongue
• Sores, ulcers, or white spots on the lips or in the mouth
• Sweating
• Talking or acting with excitement that you cannot control
• Tightness in the chest
• Trembling or shaking
• Twitching
• Unable to speak
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Upper right abdominal or stomach pain
• Vomiting
• Yellow eyes and skin

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

Symptoms of overdose

• Bloody or cloudy urine
• Change in consciousness
• Chest pain or discomfort
• Cold and clammy skin
• Coughing that sometimes produces a pink frothy sputum
• Decreased awareness or responsiveness
• Difficulty or trouble breathing
• Extreme drowsiness
• General feeling of discomfort or illness
• Increased sweating
• Irregular, fast, slow, or shallow breathing
• Irregular heartbeat
• Lightheadedness, dizziness, or fainting
• Loss of consciousness
• No blood pressure or pulse
• No muscle tone or movement
• Not breathing
• Pale or blue lips, fingernails, or skin
• Severe sleepiness
• Slow or irregular heartbeat
• Stopping of heart
• Sudden decrease in the amount of urine
• Swelling in the legs and ankles
• Unpleasant breath odor

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

More common

• Drowsiness
• Relaxed and calm feeling
• Sleepiness

Incidence not known

• Belching
• Changes in mood
• Difficulty having a bowel movement
• Fear or nervousness
• Feeling of indigestion
• Hearing loss
• Impaired hearing
• Pain in the chest below the breastbone
• Unusual drowsiness, dullness, tiredness, weakness, or feeling sluggish

Other side effects not listed may also happen 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.

• Anexsia
• Ceta Plus
• Co-Gesic
• Dolorex Forte
• Hycet
• Lorcet
• Lortab
• Maxidone
• Norco
• Stagesic
• Vicodin HP
• Zydone

Available Dosage Forms:

• Solution
• Tablet
• Elixir

Therapeutic Class: Opioid/Acetaminophen Combination

Chemical Class: Hydrocodone

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. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose. Large amounts of acetaminophen may cause liver damage.

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of hydrocodone and acetaminophen combination. This medicine should also come with a Medication Guide and patient information leaflet. 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.

Measure the oral liquid with a marked measuring spoon, oral syringe, dropper, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

This combination medicine contains acetaminophen (Tylenol®). 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).

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 moderate to severe pain: For oral dosage form (capsules): Adults—1 or 2 capsules every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 8 capsules per day. Children—Use and dose must be determined by your doctor. For oral dosage form (elixir): Adults and children 14 years of age and older and weighing 46 kilograms (kg) and more—11.25 milliliters (mL) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 67.5 mL per day. Children 10 to 13 years of age and weighing 32 to 45 kg—7.5 mL every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 45 mL per day. Children 7 to 9 years of age and weighing 23 to 31 kg—5.6 mL every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 33.6 mL per day. Children 4 to 6 years of age and weighing 16 to 22 kg—3.75 mL every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 22.5 mL per day. Children 2 to 3 years of age and weighing 12 to 15 kg—2.8 mL every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 16.8 mL per day. Children younger than 2 years of age—Use and dose must be determined by your doctor. For oral dosage form (7.5 milligrams [mg] per 325 mg per 15 mL solution): Adults and children 14 years of age and older and weighing 46 kg and more—15 milliliters (mL) or 1 tablespoonful every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 90 mL (6 tablespoonfuls) per day. Children 10 to 13 years of age and weighing 32 to 45 kg—10 mL (2 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mL (12 teaspoonfuls) per day. Children 7 to 9 years of age and weighing 23 to 31 kg—7.5 mL (1 and 1/2 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 45 mL (9 teaspoonfuls) per day. Children 4 to 6 years of age and weighing 16 to 22 kg—5 mL (1 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 30 mL (6 teaspoonfuls) per day. Children 2 to 3 years of age and weighing 12 to 15 kg—3.75 mL (3/4 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 22.5 mL (4 and 1/2 teaspoonfuls) per day. Children younger than 2 years of age—Use and dose must be determined by your doctor. For oral dosage form (10 milligrams [mg] per 325 mg per 15 mL solution): Adults—15 milliliters (mL) or 1 tablespoonful every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 90 mL (6 tablespoonfuls) per day. Children 14 years of age and older and weighing 46 kg and more—11.25 mL (2 and 1/4 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 67.5 mL (13 and 1/2 teaspoonfuls) per day. Children 10 to 13 years of age and weighing 32 to 45 kg—7.5 mL (1 and 1/2 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 45 mL (9 teaspoonfuls) per day. Children 7 to 9 years of age and weighing 23 to 31 kg—5.6 mL (1 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 33.6 mL (6 and 1/2 teaspoonfuls) per day. Children 4 to 6 years of age and weighing 16 to 22 kg—3.75 mL (3/4 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 22.5 mL (4 and 1/2 teaspoonfuls) per day. Children 2 to 3 years of age and weighing 12 to 15 kg—2.8 mL (1/2 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 16.8 mL (3 and 1/4 teaspoonfuls) per day. Children younger than 2 years of age—Use and dose must be determined by your doctor. For oral dosage form (5 milligrams [mg] per 325 mg tablets): Adults— Lortab®: 1 or 2 tablets every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 12 tablets per day. Norco® 5/325: 1 or 2 tablets every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 8 tablets per day. Generic: Dose depends on the strength of the tablet and must be determined by your doctor. Children—Use and dose must be determined by your doctor. For oral dosage form (7.5 mg per 325 mg tablets): Adults— Lortab®: 1 tablet every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 6 tablets per day. Norco® 7.5/325: 1 tablet every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 6 tablets per day. Generic: Dose depends on the strength of the tablet and must be determined by your doctor. Children—Use and dose must be determined by your doctor. For oral dosage form (10 mg per 325 mg tablets): Adults— Lortab®: 1 tablet every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 6 tablets per day. Norco® 10/325: 1 tablet every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 6 tablets per day. Generic: Dose depends on the strength of the tablet and must be determined by your doctor. Children—Use and dose must be determined by your doctor.

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.

If you miss a dose of hydrocodone and acetaminophen oral solution or Norco®, skip the missed dose and go back to your regular dosing schedule.

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.

Hydrocodone can cause serious unwanted effects or fatal overdose if taken by children, pets, or adults who are not used to strong narcotic pain medicines. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

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.

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