United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals llc - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen 300 mg - acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration (see warnings ), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): - have not been tolerated or are not expected to be tolerated. - have not provided adequate analgesia or are not expected to provide adequate analgesia. acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. acetaminophen and codeine phosphate tablets are contraindicated for: - all children younger than 12 years of age (see warnings ). all children younger than 12 years of age (see warnings ). - post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see warnings ). post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see warnings ). acetaminophen and codeine phosphate tablets are contraindicated in patients with: - significant respiratory depression (see warnings ). significant respiratory depression (see warnings ). - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (see warnings ). acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (see warnings ). - concurrent use of monoamine oxidase inhibitors (maois) or use of maois within the last 14 days (see warnings ). concurrent use of monoamine oxidase inhibitors (maois) or use of maois within the last 14 days (see warnings ). - known or suspected gastrointestinal obstruction, including paralytic ileus (see warnings ). known or suspected gastrointestinal obstruction, including paralytic ileus (see warnings ). - hypersensitivity to codeine, acetaminophen, or any of the formulation excipients (e.g., anaphylaxis) (see warnings ). hypersensitivity to codeine, acetaminophen, or any of the formulation excipients (e.g., anaphylaxis) (see warnings ). controlled substance acetaminophen and codeine phosphate tablets contain codeine. codeine in combination with acetaminophen, is a schedule iii controlled substance. abuse acetaminophen and codeine phosphate tablets contain codeine phosphate, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction (see warnings ). misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of acetaminophen and codeine phosphate tablets increases risk of overdosage, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. the risk is increased with concurrent abuse of acetaminophen and codeine phosphate tablets with alcohol and other cns depressants. abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. in addition, abuse of opioids can occur in the absence of addiction. all patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. patients at high risk of acetaminophen and codeine phosphate tablets abuse include those with a history of prolonged use of any opioid, including products containing codeine phosphate, those with a history of drug or alcohol abuse, or those who use acetaminophen and codeine phosphate tablets in combination with other abused drugs. “drug-seeking” behavior is very common in persons with substance use disorders. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. acetaminophen and codeine phosphate tablets, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of acetaminophen and codeine phosphate tablets abuse of acetaminophen and codeine phosphate tablets poses a risk of overdose and death. the risk is increased concurrent use of acetaminophen and codeine phosphate tablets with alcohol and/or other cns depressants. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. both tolerance and physical dependence can develop during use of opioid therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. do not abruptly discontinue acetaminophen and codeine phosphate tablets in a patient physically dependent on opioids. rapid tapering of acetaminophen and codeine phosphate tablets in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. when discontinuing acetaminophen and codeine phosphate tablets, gradually taper the dosage using a patient-specific plan that considers the following: the dose of acetaminophen and codeine phosphate tablets the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. to improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. in patients taking opioids for an extended period of time at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper (see dosage and administration, and warnings ). infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs (see precautions;  pregnancy) . 

United States - English - NLM (National Library of Medicine)

mylan institutional inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen 300 mg - acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - have not provided adequate analgesia, or are not expected to provide adequate analgesia, - have not been tolerated, or are not expected to be tolerated. acetaminophen and codeine phosphate tablets are contraindicated for: - all children younger than 12 years of age [see warnings ]. - post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see warnings ]. acetaminophen and codeine phosphate tablets are contraindicated in patients with: - significant respiratory depression [see warnings ].

United States - English - NLM (National Library of Medicine)

american health packaging - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen 300 mg - acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - have not provided adequate analgesia, or are not expected to provide adequate analgesia, - have not been tolerated, or are not expected to be tolerated. acetaminophen and codeine phosphate tablets are contraindicated for: - all children younger than 12 years of age [see warnings ]. - post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see warnings ]. acetaminophen and codeine phosphate tablets are contraindicated in patients with: - significant respiratory depression [

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - chlordiazepoxide (unii: 6rz6xez3cr) (chlordiazepoxide - unii:6rz6xez3cr), amitriptyline hydrochloride (unii: 26lud4jo9k) (amitriptyline - unii:1806d8d52k) - chlordiazepoxide 5 mg - chlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. the therapeutic response to chlordiazepoxide and amitriptyline hydrochloride tablets occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone. symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia. chlordiazepoxide and amitriptyline hydrochloride tablets are contraindicated in patients with hypersensitivity to either benzodiazepines or tricyclic antidepressants. it should not be given concomitantly with a monoamine oxidase inhibitor. hyperpyretic crises, severe convulsions and deaths have occurred in patients receiving a tricyclic antidepressant and a monoamine oxidase inhibitor simultaneously. when it is desired to replace a monoamine oxidase inhibitor with chlordiazepoxide and amitriptyline hydrochloride tablets, a minimum of 14 days should be allowed to elapse after the former is discontinued. chlordiazepoxide and amitriptyline hydrochloride tablets should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. this drug is contraindicated during the acute recovery phase following myocardial infarction. chlordiazepoxide and amitriptyline hydrochloride tablets contain chlordiazepoxide, a schedule iv controlled substance. chlordiazepoxide and amitriptyline hydrochloride tablets are a benzodiazepine and a cns depressant with a potential for abuse and addiction. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. abuse and misuse of benzodiazepines may lead to addiction. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see warnings: abuse, misuse, and addiction). the following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. the following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. death is more often associated with polysubstance use (especially benzodiazepines with other cns depressants such as opioids and alcohol). chlordiazepoxide and amitriptyline hydrochloride tablets may produce physical dependence from continued therapy. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see warnings: dependence and withdrawal reactions). to reduce the risk of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide and amitriptyline hydrochloride tablets or reduce the dosage (see dosage and administration: discontinuation or dosage reduction of chlordiazepoxide and amitriptyline hydrochloride tablets and warnings: dependence and withdrawal reactions). acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. more severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidality. protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. protracted withdrawal symptoms may last weeks to more than 12 months. as a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used. tolerance to chlordiazepoxide and amitriptyline hydrochloride tablets may develop from continued therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). tolerance to the therapeutic effect of chlordiazepoxide and amitriptyline hydrochloride tablets may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Australia - English - Department of Health (Therapeutic Goods Administration)

caruso's natural health pty ltd - colloidal anhydrous silica, quantity: 107 mg/g (equivalent: silicon, qty 50 mg/g); magnesium amino acid chelate, quantity: 5 mg/g (equivalent: magnesium, qty 1 mg/g); magnesium citrate, quantity: 154.7 mg/g (equivalent: magnesium, qty 25 mg/g); magnesium orotate dihydrate, quantity: 15.62 mg/g (equivalent: magnesium, qty 1 mg/g); magnesium phosphate pentahydrate, quantity: 121.06 mg/g (equivalent: magnesium, qty 25 mg/g); taurine, quantity: 200 mg/g; magnesium glycinate, quantity: 35.46 mg/g (equivalent: magnesium, qty 5 mg/g); ascorbic acid, quantity: 10 mg/g; magnesium aspartate dihydrate, quantity: 40 mg/g (equivalent: magnesium, qty 3 mg/g); zinc oxide, quantity: 3.75 mg/g (equivalent: zinc, qty 3 mg/g) - powder, oral - excipient ingredients: citric acid; colloidal anhydrous silica; maltodextrin; steviol glycosides; colour; flavour - antioxidant/reduce free radicals formed in the body ; helps reduce/decrease free radical damage to body cells ; maintain/support collagen formation ; maintain/support collagen health ; maintain/support energy production ; temporarily relieve mild fluid retention ; maintain/support general health and wellbeing ; maintain/support hair health ; maintain/support nail health/strength/thickness ; maintain/support connective tissue health ; aid/assist/helps connective tissue production/formation ; maintain/support bone health ; maintain/support cardiovascular system health ; maintain/support healthy cardiovascular system function ; maintain/support heart health ; maintain/support immune system health ; maintain/support immune system to fight illness ; helps stimulate a healthy immune system response ; decrease/reduce/relieve muscle cramps ; helps reduce occurrence of muscle cramp ; helps decrease/reduce/relieve mild muscle spasms/twitches ; maintain/support healthy muscle contraction function ; maintain/support muscle health ; maintain/support muscle function ; maintain/support muscle relaxation ; aid/assist/helps glucose/sugar/carbohydrate metabolism ; helps prevent dietary (state vitamin/mineral/nutrient) deficiency ; aid/assist/helps metabolism of (state vitamin/mineral/nutrient) ; maintain/support (state vitamin/mineral) within normal range ; support healthy stress response in the body ; maintain/support nervous system health ; maintain/support nervous system function ; decrease/reduce/relieve menstrual spasms/cramps ; decrease/reduce/relieve mood changes/mood swings associated with premenstrual tension ; decrease/reduce/relieve breast pain/tenderness associated with premenstrual tension ; decrease/reduce/relieve symptoms of premenstrual tension ; maintain/support reproductive system health ; maintain/support healthy reproductive hormones ; helps maintain/support testosterone formation/synthesis ; maintain/support semen health ; maintain/support sperm health ; maintain/support sperm motility ; maintain/support sperm production ; maintain/support testosterone level ; maintain/support skin health

Australia - English - Department of Health (Therapeutic Goods Administration)

blackmores ltd - heavy magnesium oxide, quantity: 45.7 mg (equivalent: magnesium, qty 27.5 mg); zinc amino acid chelate, quantity: 75 mg (equivalent: zinc, qty 15 mg); magnesium phosphate pentahydrate, quantity: 121 mg (equivalent: magnesium, qty 25 mg); manganese amino acid chelate, quantity: 20 mg (equivalent: manganese, qty 2 mg); retinol acetate, quantity: 0.8843 mg (equivalent: vitamin a, qty 0.7497 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; colloidal anhydrous silica; hypromellose; magnesium stearate; titanium dioxide; macrogol 8000; maize starch; acacia; dl-alpha-tocopherol; spray-dried glucose syrup - maintain/support healthy immune system function ; maintain/support reproductive system health ; maintain/support skin health

United States - English - NLM (National Library of Medicine)

redpharm drug, inc. - codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - acetaminophen 300 mg - acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain,where treatment with an opioid is appropriate and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings], reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] have not provided adequate analgesia, or are not expected to provide adequate analgesia have not been tolerated, or are not expected to be tolerated acetaminophen and codeine phosphate tablets are contraindicated in patients with: patients with significant respiratory depression [see warnings]. patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings]. postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy [see warni

United States - English - NLM (National Library of Medicine)

specgx llc - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen 300 mg - acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see warnings ), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) - have not provided adequate analgesia, or are not expected to provide adequate analgesia, have not provided adequate analgesia, or are not expected to provide adequate analgesia, - have not been tolerated, or are not expected to be tolerated. acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. acetaminophen and codeine phosphate tablets are contraindicated for: - all children younger than 12 years of age (see  warnings ). - postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see  warnings ). acetaminophen and codeine phosphate tablets are contraindicated in patients with: - significant respiratory depression (see  warnings ). - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (see  warnings ). - concurrent use of monoamine oxidase inhibitors (maois) or use of maois within the last 14 days (see  warnings ). - known or suspected gastrointestinal obstruction, including paralytic ileus (see  warnings ). - hypersensitivity to codeine, acetaminophen, or any of the formulation excipients (e.g., anaphylaxis) (see  warnings ). controlled substance acetaminophen and codeine phosphate tablets contain codeine. codeine in combination with acetaminophen, is a schedule iii controlled substance. abuse acetaminophen and codeine phosphate tablets contain, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction (see  warnings ). misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of acetaminophen and codeine phosphate tablets increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. the risk is increased with concurrent abuse of acetaminophen and codeine phosphate tablets with alcohol and other cns depressants. abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. in addition, abuse of opioids can occur in the absence of addiction. all patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. patients at high risk of acetaminophen and codeine phosphate tablets abuse include those with a history of prolonged use of any opioid, including products containing codeine, those with a history of drug or alcohol abuse, or those who use acetaminophen and codeine phosphate tablets in combination with other abused drugs. “drug-seeking” behavior is very common in persons with substance use disorders. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. acetaminophen and codeine phosphate tablets, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of acetaminophen and codeine phosphate tablets abuse of acetaminophen and codeine phosphate tablets poses a risk of overdose and death. the risk is increased with concurrent use of acetaminophen and codeine phosphate tablets with alcohol and/or other cns depressants. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. dependence both tolerance and physical dependence can develop during chronic opioid therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. do not abruptly discontinue acetaminophen and codeine phosphate tablets in a patient physically dependent on opioids. rapid tapering of acetaminophen and codeine phosphate tablets in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. when discontinuing acetaminophen and codeine phosphate tablets, gradually taper the dosage using a patient-specific plan that considers the following: the dose of acetaminophen and codeine phosphate tablets the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. to improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. in patients taking opioids for a long duration at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper (see dosage and administration  and warnings ). infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs (see  precautions, pregnancy ).

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen 300 mg - acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see warnings ), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) - have not provided adequate analgesia, or are not expected to provide adequate analgesia, have not provided adequate analgesia, or are not expected to provide adequate analgesia, - have not been tolerated, or are not expected to be tolerated. acetaminophen and codeine phosphate tablets are contraindicated for: - all children younger than 12 years of age (see  warnings ). - postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see  warnings ). acetaminophen and codeine phosphate tab

United States - English - NLM (National Library of Medicine)

cardinal health 107, llc - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen 300 mg - acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see warnings ), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) acetaminophen and codeine phosphate tablets are contraindicated for: acetaminophen and codeine phosphate tablets are contraindicated in patients with: controlled substance acetaminophen and codeine phosphate tablets contain codeine. codeine in combination with acetaminophen, is a schedule iii controlled substance. abuse acetaminophen and codeine phosphate tablets contain codeine, a substance with a high potential for abuse similar to other opioids, including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, a