TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN- tramadol hydrochloride and acetaminophen tablet, film coated
Sun Pharmaceutical Industries, Inc.
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Medication Guide Tramadol Hydrochloride ( tram a dol hye” droe cklo’ ride) and Acetaminophen( a seet” a min’oh fen) Tablets, CIV |
Tramadol hydrochloride and acetaminophen tablets are: •A strong prescription pain medicine that contains an opioid (narcotic) that is used for the short-term (five days or less) management of acute 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 tramadol hydrochloride and acetaminophen tablets: • Get emergency help or call 911 right away if you take too much tramadol hydrochloride and acetaminophen tablets (overdose).When you first start taking tramadol hydrochloride and acetaminophen 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. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose. •Tramadol hydrochloride and acetaminophen tablets can cause severe drowsiness, breathing problems (respiratory depression), coma and death when taken with benzodiazepines or other medicines that depress consciousness. •Never give anyone else your tramadol hydrochloride and acetaminophen tablets. They could die from taking it. Selling or giving away tramadol hydrochloride and acetaminophen tablets are against the law. •Store tramadol hydrochloride and acetaminophen tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. •Get emergency help right away if you take more than 4,000 mg of acetaminophen in 1 day. Taking tramadol hydrochloride and acetaminophen tablets with other products that contain acetaminophen can lead to serious liver problems and death. |
Important information guiding use in pediatric patients: •Do not give tramadol hydrochloride and acetaminophen tablets to a child younger than 12 years of age. •Do not give tramadol hydrochloride and acetaminophen tablets to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids. •Avoid giving tramadol hydrochloride and acetaminophen tablets to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems. Do not take tramadol hydrochloride and acetaminophen tablets if you have: •Severe asthma, trouble breathing, or other lung problems. •A bowel blockage or have narrowing of the stomach or intestines. •An allergy to any of its ingredients (e.g., tramadol hydrochloride or acetaminophen). •Taken a Monoamine Oxidase Inhibitor, MAOI, (medicine used for depression) within the last 14 days. |
Before taking tramadol hydrochloride and acetaminophen tablets, tell your healthcare provider if you have a history of:
Tell your healthcare provider if you are:
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When taking tramadol hydrochloride and acetaminophen tablets:
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While taking tramadol hydrochloride and acetaminophen tablets DO NOT: •Drive or operate heavy machinery, until you know how tramadol hydrochloride and acetaminophen tablets affect you. Tramadol hydrochloride and acetaminophen tablets can make you sleepy, dizzy, or lightheaded. •Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with tramadol hydrochloride and acetaminophen tablets may cause you to overdose and die. |
The possible side effects of tramadol hydrochloride and acetaminophen tablets are: •constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.Get emergency medical help or call 911 right away if you have: •trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.These are not all the possible side effects of tramadol hydrochloride and acetaminophen tablets. Call your healthcare providerfor medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov Distributed By: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 www.sunpharma.com or call 1-800-406-7984 |
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Rev. 01/2024