White oval pill with u03

Risk cannot be ruled out during pregnancy. What is the most important information I should know about acetaminophen and hydrocodone? Keep the medication in a place where others cannot get to it.

If you are a consumer or patient please visit this version. Addiction, Abuse, and Misuse Hydrocodone bitartrate and acetaminophen tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate and acetaminophen tablets. Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate and acetaminophen tablets or following a dose increase [see WARNINGS ].

White oval pill with u03

If you are a consumer or patient please visit this version. Hydrocodone bitartrate and acetaminophen tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Serious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate and acetaminophen tablets. Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate and acetaminophen tablets or following adose increase [see WARNINGS ]. Accidental ingestion of even one dose of hydrocodone bitartrate and acetaminophen tablets, especially by children, can result in a fatal overdose of Hydrocodone bitartrate and acetaminophen tablets[see WARNINGS ]. Prolonged use of hydrocodone bitartrate and acetaminophen tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized andtreated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in apregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS ]. Acetaminophenhas been associated with cases of acute liver failure, at times resulting inliver transplant and death. Most of the cases of liver injury are associatedwith the use of acetaminophen at doses that exceed 4, milligrams per day,and often involve more than one acetaminophen-containing product see WARNINGS. Concomitant use of opiods with benzodiazepines or other central nervous system CNS depressants including alcohol, may result in profound sedation, respiratory depression, coma, and death. Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder.

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Limitations of Use Because of the risks of addiction, abuse, and misuse , with opioids, even at recommended doses [see WARNINGS ], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options [e. Each tablet contains 5 mg hydrocodone bitartrate and mg acetaminophen. Each tablet contains 7. Each tablet contains 10 mg hydrocodone bitartrate and mg acetaminophen. Dispense in a tight, light-resis tan t container as defined in the USP with a child-resis tan t closure. Keep this and all medication out of the reach of children. A Schedule C-II controlled drug subs tan ce.

Risk cannot be ruled out during pregnancy. What is the most important information I should know about acetaminophen and hydrocodone? Keep the medication in a place where others cannot get to it. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have pain in your upper stomach, loss of appetite, dark urine, or jaundice yellowing of your skin or eyes. Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. Hydrocodone is an opioid pain medication, sometimes called a narcotic. Acetaminophen is a less potent pain reliever that increases the effects of hydrocodone.

White oval pill with u03

U03 is a white-colored pill that has Acetaminophen mg and Hydrocodone Bitartrate 10mg as an active ingredients. U03 Pill is used in the treatment of pain associated with cough, backache , body ache, and post-surgical pain. Acetaminophen is an analgesic painkiller that works by reducing the production of prostaglandins in the body which is responsible for pain sensation in the body.

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Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4, milligrams per day, and often involve more than one acetaminophen-containing product see WARNINGS. Long-term studies in mice and rats have been completed by the National Toxicology Program to evaluate the carcinogenic potential of acetaminophen. The usual precautions should be observed and the possibility of respiratorydepression should be kept in mind. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. It is not known whether hydrocodone isexcreted in human milk. Special Senses Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose. To obtain the best possible outcome, NAC should be administered as soon aspossible where impending or evolving liver injury is suspected. You should not use this medicine if you are allergic to acetaminophen or hydrocodone, or if you have: severe asthma or breathing problems; or a blockage in your stomach or intestines. Serotonergic Drugs The concomitantuse of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors SSRIs , serotonin andnorepinephrine reuptake inhibitors SNRIs , tricyclic antidepressants TCAs ,triptans, 5-HT 3 receptor antagonists, drugs that effect theserotonin neurotransmitter system e. Formore information go to dailymed. Contact local state professional licensing board or statecontrolled substances authority for information on how to prevent and detectabuse or diversion of this product. If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage.

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For clinically significant respiratory or circulatory depression secondary to opioid overdose, administer an opioid antagonist. Clinical Presentation Acuteoverdose with hydrocodone bitartrate and acetaminophen tablets can bemanifested by respiratory depression, somnolence progressing to stupor or coma,skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, insome cases, pulmonary edema, bradycardia, hypotension, partial or completeairway obstruction, atypical snoring, and death. Each tablet contains 10 mg hydrocodone bitartrate and mg acetaminophen. Consider these risks when prescribing ordispensing hydrocodone bitartrate and acetaminophen tablets. In addition, abuse of opioids can occur in the absence of true addiction. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. Opioids are sought by drug abusers and people with addiction disorders and aresubject to criminal diversion. These effects appear to increase with the duration of treatment. Abuse and addiction are separate and distinct from physical dependence and tolerance. Concentration—Adverse Reaction Relationships There is a relationship between increasing hydrocodone plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression. Published studies in rodents report that oral acetaminophen treatment of male animals at doses that are 1. Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, evenonce, for its rewarding psychological or physiological effects. Carcinogenesis, Mutagenesis, Impairment of Fertility Noadequate studies have been conducted in animals to determine whetherhydrocodone or acetaminophen have a potential for carcinogenesis, mutagenesis,or impairment of fertility. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates.