Acetaminophen and codeine

Name: Acetaminophen and codeine

What is acetaminophen and codeine?

Codeine is an opioid pain medication. An opioid is sometimes called a narcotic. Acetaminophen is a less potent pain reliever that increases the effects of codeine.

Acetaminophen and codeine is a combination medicine used to relieve moderate to severe pain.

Acetaminophen and codeine may also be used for other purposes not listed in this medication guide.

What happens if I miss a dose?

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of this medicine can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include extreme drowsiness, pinpoint pupils, confusion, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.

What other drugs will affect acetaminophen and codeine?

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

  • other narcotic medications--opioid pain medicine or prescription cough medicine;

  • drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or

  • drugs that affect serotonin levels in your body--medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with acetaminophen and codeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Acetaminophen and Codeine Description

Acetaminophen and Codeine phosphate tablets are available in tablet form for oral administration.

Acetaminophen, 4′-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula:

Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/15 mg) contains:

Acetaminophen USP………………..…300 mg
Codeine Phosphate USP……………….15 mg

Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/30 mg) contains:

Acetaminophen USP……………..……300 mg
Codeine Phosphate USP……………….30 mg

Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/60 mg) contains:

Acetaminophen USP……………..……300 mg
Codeine Phosphate USP……………….60 mg

In addition, each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 300 mg/15 mg Bottle

NDC 0406-0483-01

100 TABLETS

Acetaminophen and Codeine Phosphate
Tablets USP

CIII

300 mg/15 mg

Rx only

Each tablet contains:
Acetaminophen USP . . . . . . . . . . . . . . . 300 mg
Codeine Phosphate USP. . . . . . . . . . . . . 15 mg

This package is not for household use.

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Mallinckrodt™

L00A28
Rev 12/2016

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 300 mg/60 mg Bottle

NDC 0406-0485-05

500 TABLETS

Acetaminophen and Codeine Phosphate
Tablets USP

CIII

300 mg/60 mg

Each tablet contains:
Acetaminophen USP . . . . . . . . . . . . . . . 300 mg
Codeine Phosphate USP. . . . . . . . . . . . . 60 mg

Rx only

This package is not for household use.

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Mallinckrodt™

L00A37
Rev 12/2016

Acetaminophen and Codeine PHOSPHATE 
Acetaminophen and Codeine phosphate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0406-0483
Route of Administration ORAL DEA Schedule CIII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 300 mg
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 15 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)  
MAGNESIUM STEARATE  
MICROCRYSTALLINE CELLULOSE  
POVIDONE, UNSPECIFIED  
STARCH, CORN  
STEARIC ACID  
Product Characteristics
Color WHITE (to off-white) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 2;M
Contains     
Packaging
# Item Code Package Description
1 NDC:0406-0483-01 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040419 07/06/2011
Acetaminophen and Codeine PHOSPHATE 
Acetaminophen and Codeine phosphate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0406-0484
Route of Administration ORAL DEA Schedule CIII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 300 mg
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 30 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)  
MAGNESIUM STEARATE  
MICROCRYSTALLINE CELLULOSE  
POVIDONE, UNSPECIFIED  
STARCH, CORN  
STEARIC ACID  
Product Characteristics
Color WHITE (to off-white) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code 3;M
Contains     
Packaging
# Item Code Package Description
1 NDC:0406-0484-20 20 TABLET in 1 BOTTLE
2 NDC:0406-0484-03 30 TABLET in 1 BOTTLE
3 NDC:0406-0484-50 50 TABLET in 1 BOTTLE
4 NDC:0406-0484-01 100 TABLET in 1 BOTTLE
5 NDC:0406-0484-10 1000 TABLET in 1 BOTTLE
6 NDC:0406-0484-62 100 TABLET in 1 BLISTER PACK
7 NDC:0406-0484-23 1 TABLET in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040419 07/06/2011
Acetaminophen and Codeine PHOSPHATE 
Acetaminophen and Codeine phosphate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0406-0485
Route of Administration ORAL DEA Schedule CIII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 300 mg
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 60 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)  
MAGNESIUM STEARATE  
MICROCRYSTALLINE CELLULOSE  
POVIDONE, UNSPECIFIED  
STARCH, CORN  
STEARIC ACID  
Product Characteristics
Color WHITE (to off-white) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code 4;M
Contains     
Packaging
# Item Code Package Description
1 NDC:0406-0485-01 100 TABLET in 1 BOTTLE
2 NDC:0406-0485-05 500 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040419 07/06/2011
Labeler - Mallinckrodt, Inc. (047021092)
Establishment
Name Address ID/FEI Operations
MALLINCKRODT INC 957414238 ANALYSIS(0406-0483, 0406-0484, 0406-0485), MANUFACTURE(0406-0483, 0406-0484, 0406-0485)
Establishment
Name Address ID/FEI Operations
MALLINCKRODT, INC. 798275046 API MANUFACTURE(0406-0483, 0406-0484, 0406-0485)
Establishment
Name Address ID/FEI Operations
MALLINCKRODT, INC. 163205300 API MANUFACTURE(0406-0483, 0406-0484, 0406-0485)
Revised: 09/2017   Mallinckrodt, Inc.

Dosing Geriatric

Refer to adult dosing. Use with caution and consider initiation at the low end of the dosing range; titrate slowly.

Administration

Shake suspension well before administering dose.

Storage

Store at 20°C to 25°C (68°F to 77°F); protect from light.

Warnings/Precautions

Concerns related to adverse effects:

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Constipation: May cause or aggravate constipation; chronic use may result in obstructive bowel disease, particularly in those with underlying intestinal motility disorders. May also be problematic in patients with unstable angina and patients post-myocardial infarction. Consider preventive measures (eg, stool softener, increased fiber) to reduce the potential for constipation.

• Hepatotoxicity: [US Boxed Warning]: Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at dosages that exceed 4 g/day, and often involve more than one acetaminophen-containing product. Risk is increased with alcohol use, preexisting liver disease, and intake of more than one source of acetaminophen-containing medications. Chronic daily dosing in adults has also resulted in liver damage in some patients.

• Hypersensitivity/anaphylactic reactions: Hypersensitivity and anaphylactic reactions have been reported with acetaminophen use; discontinue immediately if symptoms of allergic or hypersensitivity reactions occur.

• Hypotension: May cause severe hypotension (including orthostatic hypotension and syncope); use with caution in patients with hypovolemia, cardiovascular disease (including acute MI), or drugs which may exaggerate hypotensive effects (including phenothiazines or general anesthetics). Monitor for symptoms of hypotension following initiation or dose titration. Avoid use in patients with circulatory shock.

• Phenanthrene hypersensitivity: Use with caution in patients with hypersensitivity reactions to other phenanthrene-derivative opioid agonists (hydrocodone, hydromorphone, levorphanol, oxycodone, oxymorphone).

• Respiratory depression: [US Boxed Warning]: Serious, life-threatening, or fatal respiratory depression may occur with use. Monitor for respiratory depression, especially during initiation of therapy or following a dose increase. Carbon dioxide retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.

• Skin reactions: Serious and potentially fatal skin reactions, including acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have occurred rarely with acetaminophen use. Discontinue therapy at the first appearance of skin rash or any other sign of hypersensitivity.

Disease-related concerns:

• Abdominal conditions: May obscure diagnosis or clinical course of patients with acute abdominal conditions.

• Adrenocortical insufficiency: Use with caution in patients with adrenocortical insufficiency, including Addison disease. Long-term opioid use may cause secondary hypogonadism, which may lead to sexual dysfunction, infertility, mood disorders, and osteoporosis (Brennan 2013).

• Biliary tract impairment: Use with caution in patients with biliary tract dysfunction, including acute pancreatitis; opioids may cause constriction of sphincter of Oddi.

• CNS depression/coma: Avoid use in patients with impaired consciousness or coma as these patients are susceptible to intracranial effects of CO2 retention.

• Delirium tremens: Use with caution in patients with delirium tremens.

• G6PD deficiency: Use acetaminophen with caution in patients with known G6PD deficiency.

• Head trauma: Use with extreme caution in patients with head injury, intracranial lesions, or elevated intracranial pressure; exaggerated elevation of ICP may occur.

• Hepatic impairment: Use with caution in patients with hepatic impairment. Use with caution in patients with alcoholic liver disease; consuming ≥3 alcoholic drinks/day may increase the risk of liver damage.

• Mental health conditions: Use opioids with caution for chronic pain in patients with mental health conditions (eg, depression, anxiety disorders, post-traumatic stress disorder) due to increased risk for opioid use disorder and overdose; more frequent monitoring is recommended (Dowell [CDC 2016]).

• Obesity: Use with caution in patients who are morbidly obese.

• Prostatic hyperplasia/urinary stricture: Use with caution in patients with prostatic hyperplasia and/or urinary stricture.

• Psychosis: Use with caution in patients with toxic psychosis.

• Renal impairment: Use with caution in patients with renal impairment.

• Respiratory disease: Use with caution and monitor for respiratory depression in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression, particularly when initiating and titrating therapy; critical respiratory depression may occur, even at therapeutic dosages. Consider the use of alternative nonopioid analgesics in these patients.

• Seizure disorder: Use with caution in patients with a history of seizure disorders; may cause or exacerbate seizures.

• Sleep-disordered breathing: Use opioids with caution for chronic pain and titrate dosage cautiously in patients with risk factors for sleep-disordered breathing, including HF and obesity. Avoid opioids in patients with moderate to severe sleep-disordered breathing (Dowell [CDC 2016]).

• Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.

Concurrent drug therapy issues:

• Benzodiazepines and other CNS depressants: [US Boxed Warning]: Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of acetaminophen/codeine and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

• Cytochrome P450 3A4 interactions: [US Boxed Warning]: The concomitant use of codeine with all cytochrome P450 3A4 inhibitors or discontinuation of a CYP450 3A4 inducer may result in an increase in codeine plasma concentrations with subsequently greater metabolism by CYP450 2D6, resulting in greater morphine levels, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. The concomitant use of codeine with all CYP450 3A4 inducers or discontinuation of a CYP450 3A4 inhibitor may result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels. The concomitant use of codeine with all CYP450 2D6 inhibitors may result in an increase in codeine plasma concentrations and a decrease in the plasma concentration of the active metabolite, morphine. The discontinuation of a CYP450 2D6 inhibitor may result in a decrease in codeine plasma concentrations and an increase in the plasma concentration of the active metabolite, morphine. Follow patients receiving acetaminophen/codeine and any CYP2D6 inhibitor or CYP3A4 inhibitor or inducer for signs and symptoms that may reflect opioid toxicity and opioid withdrawal when acetaminophen/codeine are used in conjunction with inhibitors of CYP2D6 or inhibitors and inducers of CYP3A4.

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• CYP2D6 “ultrarapid metabolizers”: Use caution in patients with two or more copies of the variant CYP2D6*2 allele; may have extensive conversion to morphine and thus increased opioid-mediated effects. Avoid the use of codeine in these patients; consider alternative analgesics such as morphine or a nonopioid agent (Crews 2012). The occurrence of this phenotype is seen in 0.5% to 1% of Chinese and Japanese, 0.5% to 1% of Hispanics, 1% to 10% of Caucasians, 3% of African-Americans, and 16% to 28% of North Africans, Ethiopians, and Arabs.

• Cachectic or debilitated patients: Use with caution in cachectic or debilitated patients; there is a greater potential for critical respiratory depression, even at therapeutic dosages. Consider the use of alternative nonopioid analgesics in these patients.

• Elderly: Use with caution in the elderly; may be more sensitive to adverse effects, such as respiratory depression. Use opioids for chronic pain with caution in this age group; monitor closely due to an increased potential for risks, including certain risks such as falls/fracture, cognitive impairment, and constipation. Clearance may also be reduced in older adults (with or without renal impairment) resulting in a narrow therapeutic window and increasing the risk for respiratory depression or overdose (Dowell [CDC 2016]). Consider the use of alternative nonopioid analgesics in these patients.

• Neonates: Neonatal withdrawal syndrome: [US Boxed Warning]: Prolonged use during pregnancy can cause neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Signs and symptoms include irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. Onset, duration, and severity depend on the drug used, duration of use, maternal dose, and rate of drug elimination by the newborn.

• Pediatric: [US Boxed Warning]: Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and were found to have evidence of being ultrarapid metabolizers of codeine due to a CYP2D6 polymorphism; children with obstructive sleep apnea may be at increased risk. Deaths have also occurred in nursing infants after being exposed to high concentrations of morphine because the mothers were ultrarapid metabolizers. Use is contraindicated in the postoperative pain management of children who have undergone tonsillectomy and/or adenoidectomy.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer's labeling.

• Metabisulfite: Some products may contain metabisulfite which may cause allergic reactions.

• Oral suspensions: [US Boxed Warning]: Dosing errors due to confusion between mg and mL, and other acetaminophen/codeine oral suspensions of different concentrations can result in accidental overdose and death. Ensure accuracy when prescribing, dispensing, and administering oral suspension.

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP ["Inactive" 1997]; Zar 2007).

Other warnings/precautions:

• Abuse/misuse/diversion: [US Boxed Warning]: Use exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing acetaminophen/codeine, and monitor all patients regularly for the development of these behaviors or conditions. Use with caution in patients with a history of drug abuse or acute alcoholism; potential for drug dependency exists. Other factors associated with increased risk for misuse include younger age, concomitant depression (major), and psychotropic medication use. Consider offering naloxone prescriptions in patients with factors associated with an increased risk for overdose, such as history of overdose or substance use disorder, higher opioid dosages (≥50 morphine milligram equivalents/day orally), and concomitant benzodiazepine use (Dowell [CDC 2016]). Abuse or misuse of ER tablets by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of the oxycodone and can result in overdose and death.

• Accidental ingestion: [US Boxed Warning]: Accidental ingestion of even one dose of acetaminophen/codeine, especially by children, can result in a fatal overdose of codeine.

• Appropriate use: Chronic pain (outside of end-of-life or palliative care, active cancer treatment, sickle cell disease, or medication-assisted treatment for opioid use disorder) in outpatient setting in adults: Opioids should not be used as first-line therapy for chronic pain management (pain >3-month duration or beyond time of normal tissue healing) due to limited short-term benefits, undetermined long-term benefits, and association with serious risks (eg, overdose, MI, auto accidents, risk of developing opioid use disorder). Preferred management includes nonpharmacologic therapy and nonopioid therapy (eg, NSAIDs, acetaminophen, certain anticonvulsants and antidepressants). If opioid therapy is initiated, it should be combined with nonpharmacologic and nonopioid therapy, as appropriate. Prior to initiation, known risks of opioid therapy should be discussed and realistic treatment goals for pain/function should be established, including consideration for discontinuation if benefits do not outweigh risks. Therapy should be continued only if clinically meaningful improvement in pain/function outweighs risks. Therapy should be initiated at the lowest effective dosage using immediate-release opioids (instead of extended-release/long-acting opioids). Risk associated with use increases with higher opioid dosages. Risks and benefits should be re-evaluated when increasing dosage to ≥50 morphine milligram equivalents (MME)/day orally; dosages ≥90 MME/day orally should be avoided unless carefully justified (Dowell [CDC 2016]).

• Dosage limit: Limit acetaminophen dose from all sources (prescription, OTC, combination products) to <4 g/day in adults. Do not use acetaminophen/codeine concomitantly with other acetaminophen-containing products.

• Optimal regimen: An opioid-containing analgesic regimen should be tailored to each patient's needs and based upon the type of pain being treated (acute versus chronic), the route of administration, degree of tolerance for opioids (naive versus chronic user), age, weight, and medical condition. The optimal analgesic dose varies widely among patients; doses should be titrated to pain relief/prevention.

• Surgery: Opioids decrease bowel motility; monitor for decreased bowel motility in postop patients receiving opioids. Use with caution in the perioperative setting; individualize treatment when transitioning from parenteral to oral analgesics.

• Withdrawal: Concurrent use of mixed agonist/antagonist (eg, pentazocine, nalbuphine, butorphanol) or partial agonist (eg, buprenorphine) analgesics may precipitate withdrawal symptoms and/or reduced analgesic efficacy in patients following prolonged therapy with mu opioid agonists. Abrupt discontinuation following prolonged use may also lead to withdrawal symptoms. Taper dose gradually when discontinuing.

Pregnancy Risk Factor C Pregnancy Considerations

Animal reproduction studies have not been conducted with this combination. [US Boxed Warning]: Prolonged use of opioids during pregnancy can cause neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Refer to individual agents.

Description

TYLENOL® with Codeine is supplied in tablet form for oral administration.

Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

C8H9NO2   M.W. 151.16

Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula:

C18H21NO3•H3PO4•1/2 H2O   M.W. 406.37

Each tablet contains:

Acetaminophen. . . . . . . . . . . . . . . . . . . 300 mg
No. 3 Codeine Phosphate . . . . . . . . . . . 30 mg
(Warning: May be habit forming)

Acetaminophen. . . . . . . . . . . . . . . . . . . 300 mg
No. 4 Codeine Phosphate . . . . . . . . . . . 60 mg
(Warning: May be habit forming)

In addition, each tablet contains the following inactive ingredients:

TYLENOL® with Codeine (acetaminophen and codeine) No. 3 contains powdered cellulose, magnesium stearate, sodium metabisulfite†, pregelatinized starch (corn), and modified starch (corn).

TYLENOL® with Codeine (acetaminophen and codeine) No. 4 contains powdered cellulose, magnesium stearate, sodium metabisulfite†, pregelatinized starch (corn), and corn starch.

†See WARNINGS

Acetaminophen and Codeine Overview

Acetaminophen/codeine is a prescription medication used to treat mild to moderately severe pain. It is a single medication containing two drugs, acetaminophen and codeine. Acetaminophen/codeine belongs to a group of drugs called analgesics, which helps stop the spread of pain signals from the brain to the body.

This medication comes in tablet and oral (by mouth) solution forms and may be taken up to 6 times a day as needed, with or without food.

Common side effects of acetaminophen/codeine include dizziness, lightheadedness, and shortness of breath.

Acetaminophen/codeine can also cause drowsiness. Do not drive or operate heavy machinery until you know how this medication will affect you. Alcohol may intensify this side effect.

Acetaminophen/codeine may result in physical dependence and is a high-risk medication for abuse.

Acetaminophen and Codeine FDA Warning

Hepatotoxicity:

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams (4 grams) per day, and often involve more than one acetaminophen-containing product.

 

  • Degenerative Disc Disease & Sciatica
  • Fever
  • Gout (Gouty Arthritis)
  • Measles
  • Menstrual Cramps
  • Neck Pain (Cervical Pain)
  • Rotator Cuff Disease
  • Sciatica
  • Shin Splints
  • Toothache

Liver Dose Adjustments

Severe hepatic impairment: Use with caution; monitor therapy with liver function tests

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