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

xspire pharma, llc - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e), dihydrocodeine bitartrate (unii: 8lxs95bsa9) (dihydrocodeine - unii:n9i9hdb855) - acetaminophen 320.5 mg - acetaminophen, caffeine, and dihydrocodeine bitartrate capsules are indicated for the management of pain severe enough to require an opioid analgesic 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, caffeine, and dihydrocodeine bitartrate 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, caffeine, and dihydrocodeine bitartrate is contraindicated for: - all children younger than 12 years of age [see warnings and precautions] - post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see warnings and precautions]. acetaminophen, caffeine, and dihydrocodeine bitartrate is also contraindicated in pati

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

preferred pharmaceuticals, 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). 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, and

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

apotheca inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen 120 mg in 5 ml - acetaminophen and codeine phosphate oral solution is indicated for the relief of mild to moderate pain. codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. this product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen. acetaminophen and codeine phosphate oral solution is classified as a schedule v controlled substance. codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. psychological dependence, physical dependence, and tolerance may develop upon repeated administration and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications.

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

pai holdings, llc - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen 120 mg in 5 ml - acetaminophen and codeine phosphate oral solution is indicated for the management of mild to moderate pain where treatment with an opioid is appropriate and for which alternative treatments are inadequate. because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve acetaminophen and codeine phosphate oral solution 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 oral solution is 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 oral solution is 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] . - patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ]. - patients with hypersensitivity to codeine, acetaminophen, or any of the formulation excipients (e.g., anaphylaxis) [see warnings ]. acetaminophen and codeine phosphate oral solution contains codeine, a schedule ii controlled substance. acetaminophen and codeine phosphate oral solution contains codeine, a substance with a high potential for abuse similar to other opioids including, including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. acetaminophen and codeine phosphate oral solution can be abused and is subject to misuse, addiction, and criminal diversion [see warnings ]. all patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. "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 drug abusers and people suffering from untreated addiction. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. abuse and addiction are separate and distinct from physical dependence and tolerance. healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. in addition, abuse of opioids can occur in the absence of true addiction. acetaminophen and codeine phosphate oral solution, like other opioids, can be diverted for non-medical 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 re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. acetaminophen and codeine phosphate oral solution is for oral use only. abuse of acetaminophen and codeine phosphate oral solution poses a risk of overdose and death. the risk is increased with concurrent use of acetaminophen and codeine phosphate oral solution with alcohol and other central nervous system 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 chronic opioid therapy. tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. physical dependence is a physiological state in which the body adapts to the drug after a period of regular exposure, resulting in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), 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 opioid usage. do not abruptly discontinue acetaminophen and codeine phosphate oral solution in a patient physically dependent on opioids. rapid tapering of acetaminophen and codeine phosphate oral solution 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 oral solution, gradually taper the dosage using a patient-specific plan that considers the following: the dose of acetaminophen and codeine phosphate oral solution 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, 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)

larken laboratories inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e), dihydrocodeine bitartrate (unii: 8lxs95bsa9) (dihydrocodeine - unii:n9i9hdb855) - acetaminophen 325 mg - acetaminophen, caffeine, and dihydrocodeine bitartrate tablets are indicated for the management of pain severe enough to require an opioid analgesic 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, caffeine, and dihydrocodeine bitartrate 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, caffeine, and dihydrocodeine bitartrate tablets are contraindicated for: - all children younger than 12 years of age [see warnings and precautions ] - post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see warnings and p

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

akorn - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen 120 mg in 5 ml - acetaminophen and codeine phosphate oral solution is 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 oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: acetaminophen and codeine phosphate oral solution is contraindicated in: acetaminophen and codeine phosphate oral solution is contraindicated in patients with: acetaminophen and codeine phosphate oral solution contains codeine. codeine in combination with acetaminophen, is a schedule v controlled substance. acetaminophen and codeine phosphate oral solution contains codeine, a substance with a high potential for abuse similar to other opioids including, including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxy

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

contract pharmacy services-pa - 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.   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: - children less than 12 years of age [see warnings  and precautions ]. - postoperative pain management in children of any age who have undergone tonsillectomy and/or adenoidectomy [see warnings  and precautions ]. - patients with sig

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)

morton grove pharmaceuticals, inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen 120 mg in 5 ml - acetaminophen and codeine phosphate oral solution is 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 oral solution 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 oral solution is 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 oral solution is contraindicated in patients with: - significant respiratory depre

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

mikart, llc - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen 120 mg in 5 ml - acetaminophen and codeine phosphate oral solution is 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 oral solution 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 oral solution is 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 oral solution is contraindicated in patients with: - significant respirat