Ceta Plus (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 or cannot be tolerated.

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

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

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 stop them from using narcotics for pain relief. Mental dependence (addiction) is unlikely to occur when narcotics are used for this reason. Physical dependence may cause withdrawal side effects if treatment is stopped suddenly. Nevertheless, severe withdrawal side effects can usually be avoided by gradually reducing the dose over time before stopping treatment completely.

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

It is very important for your doctor to check how you or your child is doing while taking this medicine, especially in the first 24 to 72 hours of treatment. This will help your doctor see if the medicine is working well and decide if you or your child should keep taking it. Blood and urine tests may be needed to check for side effects.

Do not use this medicine if you have taken an MAO inhibitor (like isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]) in the last 14 days.

It is illegal and dangerous for anyone else to take your medicine. Store your unused tablets in a safe place. People who are addicted to drugs might try to steal this medicine.

This medicine will increase the effects of alcohol and other CNS depressants (medicines that can make you sleepy or less alert). Examples of CNS depressants include antihistamines or allergy/cold medicines, sedatives, tranquilizers, sleeping pills, other prescription pain medicines or narcotics, seizure medications or barbiturates, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. There is also a higher risk of liver damage if you drink three or more alcoholic beverages while taking acetaminophen. Do not drink alcohol, and check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may be habit-forming. If you think the medicine is not working as well, do not take more than your prescribed dose.

If you believe you or someone else may have taken an overdose of this medicine, get emergency help immediately. Your doctor may give naloxone to treat an overdose. Signs of an overdose include: cold, clammy skin, coughing that sometimes produces pink frothy sputum, dark urine, 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, or yellow eyes or skin.

This medicine may cause sleep-related breathing problems (like sleep apnea, where you stop breathing for short periods while sleeping). Your doctor may lower your dose if you have sleep apnea while using this medicine.

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

Check with your doctor right away if you have 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 be signs of a serious liver problem.

This medicine may cause serious skin reactions (like acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis). Check with your doctor right away if you have 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 serious allergic reaction called anaphylaxis, which can be life-threatening and needs immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while using this medicine.

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

This medicine may make you feel dizzy, drowsy, or lightheaded. Do not drive or do anything that could be dangerous until you know how this medicine affects you.

Using narcotics for a long time can cause severe constipation. To help prevent this, your doctor may suggest that you or your child take laxatives, drink plenty of fluids, or eat more fiber. Be sure to follow the instructions carefully, since ongoing constipation can lead to 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 it altogether. This may help prevent worsening of your condition and reduce the risk of withdrawal symptoms, which can include stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.

Using this medicine during pregnancy may lead to serious unwanted effects, such as neonatal withdrawal syndrome in your newborn baby. Inform your doctor immediately if your child shows signs of an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, sneezing, weight loss, vomiting, yawning, or failure to gain weight. Check with your doctor right away if you think you are pregnant or plan to become pregnant while using this medicine.

Check with your doctor right away if you experience anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be signs of a serious condition called serotonin syndrome. Your risk may be higher if you are also taking certain other medicines that affect serotonin levels in your body.

Using too much of this medicine may cause infertility (the inability to have children). Talk to your doctor before using this medicine if you plan to have children.

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Additionally 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 problems that would limit the usefulness of hydrocodone and acetaminophen combination oral solution in children 2 years of age and older. However, 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 drowsiness, 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 taking this medicine while breastfeeding.

Interactions with Medicines

Although certain medicines 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 taking this medicine, it is especially critical 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 recommended. Your clinician may decide not to treat you with this medication or change some of the other medicines you take.

• Nalmefene
• Naltrexone
• Safinamide
• Samidorphan

Using this medication with any of the following medicines is usually not advised, but may be required in some cases. If both medications are prescribed together, your doctor 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 drug with any of the following medicines 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 often you use one or both of the medications.

• 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 drug with any of the following is usually not recommended, 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.

• Ethanol
• Grapefruit Juice
• Tobacco

Using this drug 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 clinician may change the dose or how often you use this medication, 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 drug. Make sure you inform your doctor 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 problems (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 risk for more serious side effects.

• Asthma, acute or severe 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 medication from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Not all side effects may happen, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following 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 in passing urine (dribbling)
• Difficulty with 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 immediately 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
• 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 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 have 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

• 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 of 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 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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