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Tylenol Cold Caplets Extra-Strength (Daytime) (Acetaminophen Dextromethorphan Pseudoephedrine HCl)
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Pharmacology
Information not available
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Indications
Analgesic Antipyretic Antitussive Decongestant
Analgesic Antipyretic Antitussive Decongestant
Contraindications
Known hypersensitivity to acetaminophen, pressor amines or other individual ingredients. Patients receiving or having received MAO inhibitors in the preceding 2weeks. Although pseudoephedrine is virtually without pressor effect in normotensive patients, it should be used with caution in hypertensives.
Known hypersensitivity to acetaminophen, pressor amines or other individual ingredients. Patients receiving or having received MAO inhibitors in the preceding 2weeks. Although pseudoephedrine is virtually without pressor effect in normotensive patients, it should be used with caution in hypertensives.
Safety Information / Warning
Information not available
Information not available
Precautions
As with any other nonprescription analgesic drug, physicians should be cognizant of and supervise the use of acetaminophen in patients with alcoholism, serious kidney or serious liver disease. Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive doses of acetaminophen, although reports of this event are rare. Reports usually involve cases of severe chronic alcoholics and the dosages of acetaminophen most often exceed recommended doses and often involve substantial overdose. Physicians should alert their patients who regularly consume large amounts of alcohol not to exceed the recommended doses of acetaminophen.
Patients should be counseled to consult a physician if redness or swelling is present in an area of pain, if symptoms do not improve or if they worsen, or if new symptoms such as high fever, rash, itching, excessive mucus, persistent or recurring cough or persistent headache occur, as these may be signs of a condition which requires medical attention.
Acetaminophen should not be taken for pain for more than 5days or for fever for more than 3days, unless directed by a physician.
Pregnancy and Lactation: As with any drug, patients who are pregnant or nursing a baby should consult a physician before taking this product.
Do not use with other products containing acetaminophen, salicylates or any other pain or fever medicine. Keep out of the reach of children.
In patients with high blood pressure, heart disease, diabetes, thyroid disease, difficulty in urination due to enlargement of the prostate gland, or are taking a prescription drug for high blood pressure or depression, pseudoephedrine HCl should be used with caution and only under close medical supervision. Patients with asthma, glaucoma, emphysema, chronic pulmonary disease, or shortness of breath should not use this medication unless directed by a physician.
This product should not be used for persistent or chronic cough such as occurs with smoking, asthma or emphysema unless directed by a physician.
Occupational Hazards: Preparations containing chlorpheniramine may cause drowsiness; alcoholic beverages, sedatives and tranquilizers may increase this effect and should be avoided. Advise caution when driving a motor vehicle or operating machinery or engaging in any activity requiring alertness.
Patients taking tranquilizers or sedatives should not take this medication before consulting a physician.
As with any other nonprescription analgesic drug, physicians should be cognizant of and supervise the use of acetaminophen in patients with alcoholism, serious kidney or serious liver disease. Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive doses of acetaminophen, although reports of this event are rare. Reports usually involve cases of severe chronic alcoholics and the dosages of acetaminophen most often exceed recommended doses and often involve substantial overdose. Physicians should alert their patients who regularly consume large amounts of alcohol not to exceed the recommended doses of acetaminophen.
Patients should be counseled to consult a physician if redness or swelling is present in an area of pain, if symptoms do not improve or if they worsen, or if new symptoms such as high fever, rash, itching, excessive mucus, persistent or recurring cough or persistent headache occur, as these may be signs of a condition which requires medical attention.
Acetaminophen should not be taken for pain for more than 5days or for fever for more than 3days, unless directed by a physician.
Pregnancy and Lactation: As with any drug, patients who are pregnant or nursing a baby should consult a physician before taking this product.
Do not use with other products containing acetaminophen, salicylates or any other pain or fever medicine. Keep out of the reach of children.
In patients with high blood pressure, heart disease, diabetes, thyroid disease, difficulty in urination due to enlargement of the prostate gland, or are taking a prescription drug for high blood pressure or depression, pseudoephedrine HCl should be used with caution and only under close medical supervision. Patients with asthma, glaucoma, emphysema, chronic pulmonary disease, or shortness of breath should not use this medication unless directed by a physician.
This product should not be used for persistent or chronic cough such as occurs with smoking, asthma or emphysema unless directed by a physician.
Occupational Hazards: Preparations containing chlorpheniramine may cause drowsiness; alcoholic beverages, sedatives and tranquilizers may increase this effect and should be avoided. Advise caution when driving a motor vehicle or operating machinery or engaging in any activity requiring alertness.
Patients taking tranquilizers or sedatives should not take this medication before consulting a physician.
Side Effects / Adverse Effects
The classic gastrointestinal irritation associated with nonsteroidal anti-inflammatory drugs, including ASA does not occur with acetaminophen. Sensitivity reactions are rare and may manifest as rash or urticaria. Cross-reactivity in ASA-sensitive persons has been rarely reported. If sensitivity is suspected, discontinue use of the drug.
Patients who concomitantly medicate with warfarin-type anticoagulants and regular doses of acetaminophen have occasionally been reported to have unforeseen elevations in their INR. Physicians should be cognizant of this potential interaction and monitor the INR in such patients closely while therapy is established.
Chlorpheniramine may cause excitability, especially in infants and children.
The classic gastrointestinal irritation associated with nonsteroidal anti-inflammatory drugs, including ASA does not occur with acetaminophen. Sensitivity reactions are rare and may manifest as rash or urticaria. Cross-reactivity in ASA-sensitive persons has been rarely reported. If sensitivity is suspected, discontinue use of the drug.
Patients who concomitantly medicate with warfarin-type anticoagulants and regular doses of acetaminophen have occasionally been reported to have unforeseen elevations in their INR. Physicians should be cognizant of this potential interaction and monitor the INR in such patients closely while therapy is established.
Chlorpheniramine may cause excitability, especially in infants and children.
Overdose
Symptoms and Treatment: Acetaminophen: Typical Toxidrome: Significant overdoses of acetaminophen may result in potentially fatal hepatotoxicity. The physician should be mindful that there is no early presentation that is pathoneumonic for the overdose. A high degree of clinical suspicion must always be maintained.
Due to the wide availability of acetaminophen, it is commonly involved in single and mixed drug overdose situations and the practitioner should have a low threshold for screening for its presence in a patient's serum. Acute toxicity after single dose overdoses of acetaminophen can be anticipated when the overdose exceeds 150mg/kg. Chronic alcohol abusers, cachectic individuals, and persons taking pharmacologic inducers of the hepatic P450 microsomal enzyme system may be at risk with lower exposures.
There have been rare reports of chronic intoxication in persons consuming in excess of 150mg/kg of acetaminophen daily for several days.
Specific Antidote: NAC (N-acetylcysteine) administered by either the i.v. or the oral route is known to be a highly effective antidote for acetaminophen poisoning. It is most effective when administered within 8hours of a significant overdose but reports have indicated benefits to treatment initiated well beyond this time period. It is imperative to administer the antidote as early as possible in the time course of acute intoxication to reap the full benefits of the antidote's protective effects.
General Management: When the possibility of acetaminophen overdose exists, treatment should begin immediately and include appropriate decontamination of the gastrointestinal tract, proper supportive care, careful assessment of appropriately timed serum acetaminophen estimations evaluated against the Matthew-Rumack nomogram, timely administration of NAC as required and appropriate follow-up care. Physicians unfamiliar with the current management of acetaminophen overdose should consult with a Poison Control Centre immediately. Telephone numbers for local Poison Control Centres are available in the local phone directory. Delays in initiation of appropriate therapy may jeopardize the patient's chances for full recovery.
Pseudoephedrine HCl: Typical Toxidrome: sympathomimetic/stimulant.
Specific Antidote: none.
General Management: Stabilize the patient (A, B, Cs), undertake appropriate gastrointestinal tract decontamination procedures, initiate supportive care, consult with a Regional Poison Control Centre regarding ongoing management, and arrange for appropriate follow-up care.
Chlorpheniramine Maleate: Typical Toxidrome: anticholinergic, CNS depressant (adult), CNS stimulant (child).
Specific Antidote: none.
General Management: Stabilize the patient (A, B, Cs), undertake appropriate gastrointestinal tract decontamination procedures, initiate supportive care, consult with a Regional Poison Control Centre regarding ongoing management, and arrange for appropriate follow-up care.
Dextromethorphan HBr: Typical Toxidrome: narcotic/opiate.
Specific Antidote: naloxone HCl.
General Management: Stabilize the patient (A, B, Cs), undertake appropriate gastrointestinal tract decontamination procedures, initiate supportive care, consult with a Regional Poison Control Centre regarding ongoing management, and arrange for appropriate follow-up care.
Guaifenesin: Typical Toxidrome: no reports of clinical toxicity.
Specific Antidote: none.
General Management: No specific management is required other than general supportive measures.
Symptoms and Treatment: Acetaminophen: Typical Toxidrome: Significant overdoses of acetaminophen may result in potentially fatal hepatotoxicity. The physician should be mindful that there is no early presentation that is pathoneumonic for the overdose. A high degree of clinical suspicion must always be maintained.
Due to the wide availability of acetaminophen, it is commonly involved in single and mixed drug overdose situations and the practitioner should have a low threshold for screening for its presence in a patient's serum. Acute toxicity after single dose overdoses of acetaminophen can be anticipated when the overdose exceeds 150mg/kg. Chronic alcohol abusers, cachectic individuals, and persons taking pharmacologic inducers of the hepatic P450 microsomal enzyme system may be at risk with lower exposures.
There have been rare reports of chronic intoxication in persons consuming in excess of 150mg/kg of acetaminophen daily for several days.
Specific Antidote: NAC (N-acetylcysteine) administered by either the i.v. or the oral route is known to be a highly effective antidote for acetaminophen poisoning. It is most effective when administered within 8hours of a significant overdose but reports have indicated benefits to treatment initiated well beyond this time period. It is imperative to administer the antidote as early as possible in the time course of acute intoxication to reap the full benefits of the antidote's protective effects.
General Management: When the possibility of acetaminophen overdose exists, treatment should begin immediately and include appropriate decontamination of the gastrointestinal tract, proper supportive care, careful assessment of appropriately timed serum acetaminophen estimations evaluated against the Matthew-Rumack nomogram, timely administration of NAC as required and appropriate follow-up care. Physicians unfamiliar with the current management of acetaminophen overdose should consult with a Poison Control Centre immediately. Telephone numbers for local Poison Control Centres are available in the local phone directory. Delays in initiation of appropriate therapy may jeopardize the patient's chances for full recovery.
Pseudoephedrine HCl: Typical Toxidrome: sympathomimetic/stimulant.
Specific Antidote: none.
General Management: Stabilize the patient (A, B, Cs), undertake appropriate gastrointestinal tract decontamination procedures, initiate supportive care, consult with a Regional Poison Control Centre regarding ongoing management, and arrange for appropriate follow-up care.
Chlorpheniramine Maleate: Typical Toxidrome: anticholinergic, CNS depressant (adult), CNS stimulant (child).
Specific Antidote: none.
General Management: Stabilize the patient (A, B, Cs), undertake appropriate gastrointestinal tract decontamination procedures, initiate supportive care, consult with a Regional Poison Control Centre regarding ongoing management, and arrange for appropriate follow-up care.
Dextromethorphan HBr: Typical Toxidrome: narcotic/opiate.
Specific Antidote: naloxone HCl.
General Management: Stabilize the patient (A, B, Cs), undertake appropriate gastrointestinal tract decontamination procedures, initiate supportive care, consult with a Regional Poison Control Centre regarding ongoing management, and arrange for appropriate follow-up care.
Guaifenesin: Typical Toxidrome: no reports of clinical toxicity.
Specific Antidote: none.
General Management: No specific management is required other than general supportive measures.
Recommended Dosage
Extra Strength (Daytime and Nighttime): Adults (12years of age and older): 1to 2caplets every 6to 8hours, as required. It is hazardous to exceed a combined total of any 8 Tylenol Cold caplets in a 24-hour period. Reduce dosage if nervousness or sleeplessness occurs.
Extra Strength (Daytime and Nighttime): Adults (12years of age and older): 1to 2caplets every 6to 8hours, as required. It is hazardous to exceed a combined total of any 8 Tylenol Cold caplets in a 24-hour period. Reduce dosage if nervousness or sleeplessness occurs.
Supplied / Packaging
†Container provided with a child-resistant closure.
All packages are safety sealed.
Extra-Strength (Daytime): Each yellow, film-coated caplet, engraved “TCM-ND” one side and “500” the other side, contains: pseudoephedrine HCl 30mg, dextromethorphan HBr 15mg and acetaminophen 500mg. Nonmedicinal ingredients: carnauba wax, cellulose, cornstarch, D&C Yellow No.10, FD&C Yellow No.6, hydroxypropyl methylcellulose, magnesium stearate, sodium starch glycolate, titanium dioxide and triacetin. Energy: 1.0kJ (0.2kcal). Sodium: <1mmol (0.8mg). Plastic bottles of24†. Blister packs of12.
†Container provided with a child-resistant closure.
All packages are safety sealed.
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General Indications
Analgesic Antipyretic Antitussive Decongestant
Analgesic Antipyretic Antitussive Decongestant
