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)

sunrise pharmaceutical, inc - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e), butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk) - acetaminophen 300 mg - butalbital, acetaminophen, and caffeine capsules, usp are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. caution in this regard is required because butalbital is habit-forming and potentially abusable. this product is contraindicated under the following conditions: - hypersensitivity or intolerance to any component of this product - patients with porphyria. butalbital barbiturates may be habit-forming: tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. the average daily dose for the barbiturate addict is usually about 1500 mg. as tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. as this occurs,

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

quality care products, 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 relief of mild to moderately severe pain. this product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen. acetaminophen and codeine phosphate tablets are classified as a schedule iii 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)

zydus lifesciences limited - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - acetaminophen 325 mg - tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)] , reserve tramadol hydrochloride and acetaminophen 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. tramadol hydrochloride and acetaminophen tablets are contraindicated for: -   all children younger than 12 years of age [see warnings and precautions (5.4)] -   post-operative management in children younger than 18 years of age following tonsillectomy and/or aden

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

mckesson packaging services business unit of mckesson corporation - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - acetaminophen 325 mg - acetaminophen 325mg....................analgesic/antipyretic temporary relief of minor aches and pains associated with - common cold - headache - toothache - muscular aches - backache - arthritis - menstrual cramps - and reduction of fever analgesic/antipyretic

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)

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: acetaminophen and codeine phosphate tablets contain codeine. codeine in combination with acetaminophen, a schedule iii controlled substance. 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 tapentadol. acetaminophen and c

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

nucarepharmaceuticals, inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen 300 mg - acetaminophen and codeine phosphate tablets 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 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 is contraindicated in: - 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 warnings ]. - patients with known or suspe

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)

mutual pharmaceutical company, 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 relief of mild to moderately severe pain. codeine-containing products are contraindicated for post-operative 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 tablets are classified as a schedule iii 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.