Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D), codeine phosphate (UNII: GSL05Y1MN6) (codeine anhydrous - UNII:UX6OWY2V7J)
Janssen Pharmaceuticals, Inc.
acetaminophen
acetaminophen 300 mg
ORAL
PRESCRIPTION DRUG
TYLENOL® with Codeine (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 TYLENOL® with Codeine 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. TYLENOL® with Codeine 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 ). TYLENOL® with Codeine is contraindicated in patients with: - Significant respiratory depression (see WARNINGS ). - Acute or severe bronchial asthma in an unmonitor
TYLENOL® with Codeine (acetaminophen and codeine phosphate) No. 3 Tablets contain acetaminophen 300 mg and codeine phosphate 30 mg. The tablets are white, round, flat-faced, beveled-edged, and imprinted "McNEIL" on one side and "TYLENOL CODEINE" and "3" on the other side. TYLENOL® with Codeine (acetaminophen and codeine phosphate) No. 4 Tablets contain acetaminophen 300 mg and codeine phosphate 60 mg. The tablets are white, round, flat-faced, beveled-edged, and imprinted "McNEIL" on one side and "TYLENOL CODEINE" and "4" on the other side. TYLENOL® with Codeine Tablets are supplied as follows: TYLENOL® with Codeine No. 3 bottle of 100 tablets – NDC 50458-513-60 TYLENOL® with Codeine No. 3 bottle of 1000 tablets – NDC 50458-513-80 TYLENOL® with Codeine No. 4 bottle of 100 tablets – NDC 50458-515-60 TYLENOL® with Codeine No. 4 bottle of 500 tablets – NDC 50458-515-70 Store TYLENOL® with Codeine tablets at 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Dispense in tight, light-resistant container as defined in the USP. Store TYLENOL® with Codeine tablets securely and dispose of properly (see PRECAUTIONS/ Information for Patients ). Keep out of the reach of children.
Abbreviated New Drug Application
Janssen Pharmaceuticals, Inc. ---------- MEDICATION GUIDE TYLENOL® (TAHY-LUH-NAWL) WITH CODEINE TABLETS, CIII This Medication Guide has been approved by the U.S. Food and Drug Administration. TYLENOL® with Codeine tablets are: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage mild to moderate pain, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. • An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death. Important information about TYLENOL® with Codeine tablets: • Get emergency help right away if you take too much TYLENOL® with Codeine tablets (overdose). When you first start taking TYLENOL® with Codeine tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. • Taking TYLENOL® with Codeine tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma and death. • Never give anyone else your TYLENOL® with Codeine tablets. They could die from taking it. Selling or giving away TYLENOL® with Codeine tablets is against the law. • Store TYLENOL® with Codeine tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Important Information Guiding Use in Pediatric Patients: • Do not give TYLENOL® with Codeine tablets to a child younger than 12 years of age. • Do not give TYLENOL® with Codeine tablets to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids. • Avoid giving TYLENOL® with Codeine tablets to children between 12 to 18 years of age who have risk factors for breathing problem Aqra d-dokument sħiħ
TYLENOL WITH CODEINE- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET JANSSEN PHARMACEUTICALS, INC. ---------- TYLENOL WITH CODEINE CIII (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLETS ® WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; HEPATOTOXICITY; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS ADDICTION, ABUSE AND MISUSE TYLENOL WITH CODEINE EXPOSES PATIENTS AND OTHER USERS TO THE RISKS OF OPIOID ADDICTION, ABUSE AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS EACH PATIENT'S RISK PRIOR TO PRESCRIBING TYLENOL WITH CODEINE TABLETS, AND MONITOR ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE BEHAVIORS AND CONDITIONS (SEE WARNINGS). OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS) TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF ADDICTION, ABUSE, AND MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED A REMS FOR THESE PRODUCTS (SEE WARNINGS). 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 COMPLETE A REMS-COMPLIANT EDUCATION PROGRAM, COUNSEL PATIENTS AND/OR THEIR CAREGIVERS, WITH EVERY PRESCRIPTION, ON SAFE USE, SERIOUS RISKS, STORAGE, AND DISPOSAL OF THESE PRODUCTS, EMPHASIZE TO PATIENTS AND THEIR CAREGIVERS THE IMPORTANCE OF READING THE MEDICATION GUIDE EVERY TIME IT IS PROVIDED BY THEIR PHARMACIST, AND CONSIDER OTHER TOOLS TO IMPROVE PATIENT, HOUSEHOLD, AND COMMUNITY SAFETY. LIFE-THREATENING RESPIRATORY DEPRESSION SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR WITH USE OF TYLENOL WITH CODEINE TABLETS. MONITOR FOR RESPIRATORY DEPRESSI Aqra d-dokument sħiħ