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

teva pharmaceuticals usa, 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)

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)

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)

sam's west inc - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - acetaminophen 500 mg - pain reliever/fever reducer - temporarily relieves minor aches and pains due to: backache the common cold premenstrual and menstrual cramps muscular aches headache toothache minor pain of arthritis - backache - the common cold - premenstrual and menstrual cramps - muscular aches - headache - toothache - minor pain of arthritis - temporarily reduces fever

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

aurohealth llc - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - acetaminophen 650 mg - pain reliever/fever reducer - temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache - minor pain of arthritis - muscular aches - backache - premenstrual and menstrual cramps - the common cold - headache - toothache - temporarily reduces fever - with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. - if you are allergic to acetaminophen or any of the inactive ingredients in this product. ask a doctor before use if you have liver disease. ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin - pain gets worse or lasts more than 10 days - fever gets worse or lasts more than 3 days - new symptoms occur - redness or swelling is present these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use.

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

amerisource bergen - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - acetaminophen 325 mg - pain reliever/fever reducer - temporarily relieves minor aches and pains due to: headache the common cold backache muscular aches toothache minor pain of arthritis premenstrual and menstrual cramps - headache - the common cold - backache - muscular aches - toothache - minor pain of arthritis - premenstrual and menstrual cramps - temporarily reduces fever

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

cvs pharmacy - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - acetaminophen 500 mg in 15 ml - pain reliever/fever reducer - temporarily relieves minor aches and pains due to: - muscular aches - toothache - backache - minor pain of arthritis - the common cold - premenstrual and menstrual cramps - headache - temporarily reduces fever

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

cvs pharmacy - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - acetaminophen 325 mg - pain reliever/fever reducer - temporarily relieves minor aches and pains due to: headache the common cold backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps - headache - the common cold - backache - minor pain of arthritis - toothache - muscular aches - premenstrual and menstrual cramps - temporarily reduces fever

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

cvs pharmacy, inc - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e) - pain reliever pain reliever aid treats migraine headaches may worsen if this product is used for 10 or more days per month. ■ if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer ■ with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist ■ you have never had migraines diagnosed by a health professional ■ you have a headache that is different from your usual migraines ■ you have the worst headache of your life ■ you have fever and stiff neck ■ you have headaches beginning after or caused by head injury, exertion, coughing or bending ■ you experienced your first headache after the age of 50 ■ you have daily headaches ■ you have a migraine so severe as to require bed rest ■ you have liver disease ■ stomach bleeding warning applies to you ■ you have a history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you are taking a diuretic ■ you have asthma ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ you have vomiting with your migraine headache ■ taking a prescription drug for: • diabetes • gout • arthritis ■ under a doctor’s care for any serious condition ■ taking any other drug ■ taking any other product that contains aspirin, acetaminophen or any other pain reliever/fever reducer stop use and ask a doctor if ■ an allergic reaction occurs. seek medical help right away. ■ you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better ■ your migraine is not relieved or worsens after first dose ■ new or unexpected symptoms occur ■ ringing in the ears or loss of hearing occurs

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

walgreen co - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e) - pain reliever pain reliever pain reliever aid treats migraine headaches may worsen if this product is used for 10 or more days per month. ■ if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer ■ with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist ■ you have never had migraines diagnosed by a health professional ■ you have a headache that is different from your usual migraines ■ you have the worst headache of your life ■ you have fever and stiff neck ■ you have headaches beginning after or caused by head injury, exertion, coughing or bending ■ you experienced your first headache after the age of 50 ■ you have daily headaches ■ you have a migraine so severe as to require bed rest ■ you have liver disease ■ stomach bleeding warning applies to you ■ you have a history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you are taking a diuretic ■ you have asthma ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ you have vomiting with your migraine headache ■ taking a prescription drug for: • diabetes • gout • arthritis ■ under a doctor’s care for any serious condition ■ taking any other drug ■ taking any other product that contains aspirin, acetaminophen or any other pain reliever/fever reducer stop use and ask a doctor if ■ an allergic reaction occurs. seek medical help right away. ■ you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better ■ your migraine is not relieved or worsens after first dose ■ new or unexpected symptoms occur ■ ringing in the ears or loss of hearing occurs