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TYLENOL DUAL ACTION ACETAMINOPHEN + IBUPROFEN is a brand name for Acetaminophen (also known as Paracetamol), supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TYLENOL® Dual Action Acetaminophen + Ibuprofen is indicated for temporary: ➢ relief of migraine pain ➢ relief of headaches including tension headache ➢ relief of muscle aches and pain ➢ relief of joint and body pain ➢ relief of backache ➢ relief of muscle sprains and strains ➢ relief of aches and pain due to the…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Do not take for fever for more than 3 days or for pain for more than 5 days unless directed by a physician. The lowest effective dose should be used for the shortest possible duration. TYLENOL® Dual Action Acetaminophen + Ibuprofen is not for long term use.
2 Recommended Dose and Dosage Adjustment Adults of 18 years and over: Take 2 tablets every 8 hours while symptoms persist. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Do not take more than directed (see liver warning).
Do not use longer than 3 days for a fever or 5 days for pain relief. TYLENOL® Dual Action Acetaminophen + Ibuprofen provides up to 8 hours of pain relief. 3 Administration See Recommended Dose and Dosage Adjustment. 4 Missed Dose Take the missed dose as soon as you remember.
If it is almost time for your next dose, wait until then to take your medicine and skip your missed dose. Do not take two doses at the same time.
1 Adverse Reaction Overview Safety and efficacy were evaluated in 7 clinical studies, including 3 pharmacokinetic (PK) studies, and 4 efficacy studies in pain and fever relief. The overall exposure in the clinical program included 1477 subjects, 715 of which received a dose of different Fixed Dose Combinations (FDCs) of ibuprofen/acetaminophen (varying amount of ibuprofen with the acetaminophen dose fixed at 500 mg).
There were no Serious Adverse Events (SAEs) or deaths in these studies across any of the different fixed dose combination dose groups. The intended FDC Ibuprofen (IBU) 250 mg/ Acetaminophen (APAP) 500 mg was well tolerated in the clinical program.
The most commonly reported Treatment Emergent Adverse Events (TEAEs) (≥2%) in the FDC ibuprofen 250 mg/acetaminophen 500 mg dose group were: Nausea, Vomiting, and Dizziness. No deaths, SAEs or severe Treatment Related Adverse Events (TRAEs) were reported in the clinical program.
The safety profile of the FDC was similar to the individual monocomponents. No new safety signals were identified in any subgroup (sex, age, race and FDC dose groups). 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. 7%) subjects who participated in the clinical program reported all causality Treatment-Emergent Adverse Events (TEAEs), most of which were mild or moderate in severity.
8%) subjects reported severe all causality Adverse Events (AE) (Table 1). 8%) subjects reported Treatment Related Adverse Events (TRAEs), all of which were mild or moderate in severity. No deaths, Severe Adverse Events (SAEs) or severe TRAEs were reported.
Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX General To minimize the potential risk for an adverse event, the lowest effective dose should be used for the shortest possible duration. TYLENOL® Dual Action Acetaminophen + Ibuprofen is not for long term use.
In common with other anti-inflammatory drugs, ibuprofen may mask the usual signs of infection. TYLENOL® Dual Action Acetaminophen + Ibuprofen is NOT recommended for use with other NSAIDs because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions.
(See Drug Interactions - Drug/Drug Interactions - Ibuprofen - Acetylsalicylic acid (ASA) or other NSAIDs) Patients should not take more than the recommended dose of acetaminophen, or take it with other products containing acetaminophen because severe or possibly fatal liver damage may occur.
Alcohol may potentiate the hepatotoxic effects of acetaminophen. (See Drug Interactions - Drug/Drug Interactions – Acetaminophen – Acetaminophen) In case of an overdose, medical help or a poison control center should be contacted immediately.
Prompt medical attention is critical, even in the absence of signs or symptoms. Carcinogenesis and Mutagenesis Not applicable. Cardiovascular Use of ibuprofen may precipitate congestive heart failure in patients with marginal cardiac function, elevated blood pressure and palpitations.
Long term continuous use may increase the risk of heart attack or stroke. Dependence/Tolerance Not applicable. TYLENOL® DUAL ACTION ACETAMINOPHEN + IBUPROFEN Acetaminophen 250 mg/Ibuprofen 125 mg Tablets Page 12 of 53 Ear/Nose/Throat Patients with complete or partial syndrome of nasal polyps should not use TYLENOL® Dual Action Acetaminophen + Ibuprofen (See CONTRAINDICATIONS).
Endocrine and Metabolism Not applicable. Fluid and Electrolyte Balance Fluid retention and edema have been observed in patients treated with ibuprofen. Therefore, as with many other nonsteroidal anti-inflammatory drugs, the possibility of precipitating congestive heart failure in elderly patients or those with compromised cardiac function should be borne in mind.
• Active peptic ulcer, a history of recurrent ulceration or active inflammatory disease of the gastrointestinal system. • Known or suspected hypersensitivity to acetaminophen ibuprofen or other non-steroidal anti- inflammatory drugs.
Patients who are hypersensitive to acetaminophen, ibuprofen or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph.
The potential for cross- reactivity between different NSAIDs must be kept in mind. • TYLENOL® Dual Action Acetaminophen + Ibuprofen should not be used in patients with the complete or partial syndrome of nasal polyps, or in whom asthma, anaphylaxis, urticarial/angioedema, rhinitis or other allergic manifestations are precipitated by ASA or other nonsteroidal anti-inflammatory agents.
Fatal anaphylactoid reactions have occurred in such individuals. As well, individuals with the above medical problems are at risk of a severe reaction even if they have taken NSAIDs in the past without any adverse effects. TYLENOL® DUAL ACTION ACETAMINOPHEN + IBUPROFEN Acetaminophen 250 mg/Ibuprofen 125 mg Tablets Page 5 of 53 • Hepatic impairment or active liver disease.
• Severely impaired or deteriorating renal function (creatinine clearance <30 mL/min). Individuals with lesser degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored.
• TYLENOL® Dual Action Acetaminophen + Ibuprofen is not recommended for use with other NSAIDs because of the absence of any evidence demonstrating synergistic benefits and the potential for additive side effects. • Patients should not take more than the recommended dose of acetaminophen,or take it with other products containing acetaminophen because severe or possibly fatal liver damage may occur.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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All the active treatment groups had a lower incidence of all causality AEs compared to placebo. The higher incidence of TEAEs in placebo subjects may have been due to lack of pain relief and use of opioid rescue medications in the dental pain studies, which could lead to AEs (eg, Nausea, Vomiting, and Dizziness).
The incidence of TEAEs in the monocomponent groups (ibuprofen single ingredient product and acetaminophen single ingredient product) and the Fixed Dose Combination (FDC) Total treatment group (ibuprofen and acetaminophen combination product) were similar to each other and to the Total group.
No new safety signals were identified. Table 1. 2%). The most commonly reported TEAEs (≥2%) in the clinical program were: Nausea, Vomiting, Dizziness, and Headache (Headache was reported at an incidence of ≥2% only in the placebo group).
The only TRAEs with an incidence of ≥2%, in the clinical program, were reported in the placebo group (Nausea and Vomiting). 1 Clinical Trial Adverse Reactions – Pediatrics No clinical efficacy and safety pediatric studies have been conducted for TYLENOL® Dual Action Acetaminophen + Ibuprofen.
3 Less Common Clinical Trial Adverse Reactions In the clinical program, the only treatment-related AEs with an incidence of ≥2% were reported in the placebo group (PTs: Nausea and Vomiting). No severe TRAEs were reported in any of the other treatment groups.
0%. 1%). 1%). 1%). 1%). 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings Across the 7 studies, the vital signs data (included blood pressure, pulse rate, respiration rate, and oral TYLENOL® DUAL ACTION ACETAMINOPHEN + IBUPROFEN Acetaminophen 250 mg/Ibuprofen 125 mg Tablets Page 19 of 53 temperature) were measured at baseline and at the end of study.
The majority of the readings were within the normal ranges, and the changes from baseline were not considered clinically significant. The clinical […]
TYLENOL® Dual Action Acetaminophen + Ibuprofen should be used with caution in patients with heart failure, hypertension or other conditions predisposing to fluid retention. With nonsteroidal anti-inflammatory treatment there is a potential risk of hyperkalemia, particularly in patients with conditions such as diabetes mellitus or renal failure; elderly patients; or in patients receiving concomitant therapy with ß-adrenergic blockers, angiotensin converting enzyme inhibitors or some diuretics.
Serum electrolytes should be monitored periodically during long-term therapy, especially in those patients who are at risk. Gastrointestinal Serious GI toxicity, such as peptic ulceration, perforation and gastrointestinal bleeding, sometimes severe and occasionally fatal, can occur at any time, with or without symptoms in patients treated with NSAIDs including ibuprofen.
Minor upper GI problems, such as dyspepsia, are common, usually developing early in therapy. Physicians should remain alert for ulceration and bleeding in patients treated with non-steroidal anti- inflammatory drugs, even in the absence of previous GI tract symptoms.
In patients observed in clinical trials of such agents, symptomatic upper GI ulcers, gross bleeding, or perforation appear to occur in approximately 1% of patients treated for 3-6 months and in about 2-4% of patients treated for one year.
The risk continues beyond one year and possibly increases. The incidence of these complications increases with increasing dose. TYLENOL® Dual Action Acetaminophen + Ibuprofen should be given under close medical supervision to patients prone to gastrointestinal tract irritation, particularly those with a history of peptic ulcer, diverticulosis or other inflammatory disease of the gastrointestinal tract such as ulcerative colitis and Crohn's disease.
In these cases the physician must weigh the benefits of treatment against the possible hazards. Physicians should inform patients about the signs and/or symptoms of serious GI toxicity and instruct them to contact a physician immediately if they experience persistent dyspepsia or other symptoms or signs suggestive of gastrointestinal ulceration or bleeding.
Because serious GI tract ulceration and bleeding can occur without warning symptoms, physicians should follow chronically treated patients by checking their hemoglobin periodically and by being vigilant for the signs and symptoms of ulceration and bleeding and should inform the patients of the importance of this follow-up.
If ulceration is suspected or confirmed, or if GI bleeding occurs, TYLENOL® Dual Action Acetaminophen + Ibuprofen should be discontinued immediately, appropriate treatment instituted and the patient monitored closely. No studies, to date, have identified any group of patients not at risk of developing ulceration and bleeding.
The major risk factors are a prior history of serious GI events and increasing age. Possible risk factors include other factors such as Helicobacter pylori infection, excess alcohol intake, smoking, female gender and concomitant oral steroid and anticoagulant, anti-coagulants, anti-platelet agents TYLENOL® DUAL ACTION ACETAMINOPHEN + IBUPROFEN Acetaminophen 250 mg/Ibuprofen 125 mg Tablets Page 13 of 53 (including ASA) or selective serotonin reuptake inhibitors (SSRI’s) have been associated with increased risk.
Studies to date show that all NSAIDs can cause GI tract adverse events. Although existing data does not clearly identify differences in risk between various NSAIDs, this may be shown in the future. There is no definitive evidence that the concomitant administration of histamine H2-receptor antagonists and/or antacids will either prevent the occurrence of gastrointestinal side effects or allow the continuation of TYLENOL® Dual Action Acetaminophen + Ibuprofen therapy when and if these adverse […]
Alcohol may potentiate the hepatotoxic effects of acetaminophen. • TYLENOL® Dual Action Acetaminophen + Ibuprofen should not be used during third trimester of pregnancy. • TYLENOL® Dual Action Acetaminophen + Ibuprofen should not be used right before or after heart surgery.
• TYLENOL® Dual Action Acetaminophen + Ibuprofen is contraindicated in patients with systemic lupus erythematosus, as an anaphylaxis-like reaction with fever may occur, particularly when ibuprofen has been administered previously. • Known hyperkalemia (see Warnings and Precautions - Renal - Fluid and Electrolyte Balance).
• Children and adolescents less than 18 years of age (see INDICATIONS).