Co-Gesic (Oral)

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

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

Hydrocodone is a narcotic analgesic (pain medicine) that works on the central nervous system (CNS) to relieve pain and can stop or prevent cough.

Using hydrocodone for a long time may lead to habit-forming, which can cause mental or physical dependence. However, those with ongoing pain should not let the fear of dependence stop them from using narcotics to relieve their pain. Mental dependence (addiction) is unlikely when narcotics are used for this reason. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be avoided by gradually reducing 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 will help your doctor determine if the medicine is effective and if you or your child should keep taking it. Blood and urine tests may be required to check for side effects.

Do not use this medicine if you have taken an MAO inhibitor (for example, 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. Store your unused tablets in a safe and secure location. People with drug addiction may attempt to steal this medicine.

This medicine will increase the effects of alcohol and other CNS depressants (medicines that can make you feel sleepy or less alert). Examples of CNS depressants include antihistamines or medicines for allergies or colds, sedatives, tranquilizers, sleeping medicines, other prescription pain medicines or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. Additionally, drinking three or more alcoholic beverages while taking acetaminophen may increase the risk of liver damage. Do not consume alcoholic beverages, and consult your doctor before taking any of these medicines while using this one.

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

This medicine may lead to sleep-related breathing issues (for example, sleep apnea, sleep-related hypoxemia). Your doctor may reduce your dose if you have sleep apnea (pauses in breathing during sleep) while using this medicine.

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

Inform your doctor right away if you experience pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could indicate a serious liver issue.

This medicine may lead to severe skin reactions (for example, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis). Seek medical attention immediately if you notice 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 a severe allergic reaction known as anaphylaxis, which can be life-threatening and requires urgent medical care. Call your doctor immediately if you experience a rash, itching, hoarseness, difficulty breathing, trouble swallowing, or swelling of your hands, face, or mouth while using this medicine.

Dizziness, lightheadedness, or fainting may occur when you suddenly get up from lying down or sitting. Getting up slowly may help reduce this issue. Lying down for a bit may also help 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 help prevent this, your doctor may advise you or your child to take laxatives, drink plenty of fluids, or increase fiber in your diet. Follow these instructions carefully, as ongoing constipation can lead to more serious problems.

Before you or your child undergo any medical tests, inform the medical doctor in charge that you are taking this medicine. The results of certain 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 recommend gradually reducing your dosage before stopping it entirely. This can help prevent worsening of your condition and reduce the chance of withdrawal symptoms, including stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.

Taking this medicine during pregnancy may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn. Inform your doctor immediately if your child has 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 taking this medicine.

Contact your doctor immediately if you experience anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or hallucinations. These may be signs of a serious condition known as serotonin syndrome. Your risk may increase if you take certain other medicines that affect serotonin levels in your body.

Taking too much of this medicine may cause infertility (difficulty having children). Discuss with your doctor before using this medicine if you plan to have children.

Do not take 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 medication, the chances of taking the medication must be weighed against the beneficial it will do. This is a decision you and your doctor will make. For this medication, the following should be considered:

Allergies

Inform your clinician if you have ever had any unusual or allergic reaction to this drug or any other medicines. As well inform 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 issues 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 issues 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 issues, 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 chance when using this drug during breastfeeding. Weigh the potential benefits against the potential risks prior to taking this medication while breastfeeding.

Interactions with Medications

Although certain medications should not be used together at all, in other cases two different medications may be used together even if an interaction might occur. In these cases, your physician 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 taking 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 medication 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 medications you take.

• Nalmefene
• Naltrexone
• Safinamide
• Samidorphan

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

• 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 medicine with any of the following drugs may cause an increased chance of certain adverse effects, but using both drugs may be the best therapy for you. If both drugs are prescribed together, your doctor 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 also 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 frequently you use this drug, 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 side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cabbage

Other Medical Problems

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

• Addison's disease (adrenal gland problem) 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
• Issues with passing urine—Use with caution. May increase risk for more serious side 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 necessary effects, this medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical help.

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

More common

• Dizziness
• Lightheadedness

Incidence not known

• Agitation
• Back, leg, or stomach pains
• Black, tarry stools
• Bleeding gums
• Blistering, peeling, or loosening of the skin
• Blood in the urine or stools
• Blood in vomit
• Bluish lips or skin
• Chills
• Choking
• Confusion
• Cough
• Dark urine
• Darkening of the skin
• Decrease in the frequency of urination
• Decrease in urine volume
• Diarrhea
• Difficult 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 or 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 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 these overdose symptoms 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
• Difficult or trouble breathing
• Extreme drowsiness
• General feeling of discomfort or illness
• Increased sweating
• Irregular, fast or 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 as your body gets used to the medicine. Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of these side effects continue, 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 sluggishness

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 can 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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