FDA records indicate that there are no current recalls for this drug.
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Tylenol Cold And Flu Severe Recall
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Questions & Answers
Side Effects & Adverse Reactions
This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- if you have ever had an allergic reaction to this product or any of its ingredients
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
When using this product do not exceed recommended dose
- nervousness, dizziness or sleeplessness occur
- pain, nasal congestion or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- if you have ever had an allergic reaction to this product or any of its ingredients
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Stop use and ask a doctor if- nervousness, dizziness or sleeplessness occur
- pain, nasal congestion or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
- for the temporary relief of the following cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- nasal congestion
- cough
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily reduces fever
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Tylenol Cold And Flu Severe Manufacturers
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Mcneil Consumer Healthcare Div Mcneil-ppc, Inc
Tylenol Cold And Flu Severe | Alvogen Inc.
Initial Dose
Initiate treatment with one 4.6 mg/24 hours Rivastigmine Patch applied to the skin once daily [see Dosage and Administration (2.4)].
Dose TitrationIncrease the dose only after a minimum of 4 weeks at the previous dose, and only if the previous dose has been tolerated. For mild to moderate AD and PDD patients, continue the effective dose of 9.5 mg/24 hours for as long as therapeutic benefit persists. Patients can then be increased to the maximum effective dose of 13.3 mg/24 hours dose. Doses higher than 13.3 mg/24 hours confer no appreciable additional benefit, and are associated with an increase in the incidence of adverse reactions [see Warnings and Precautions (5.2), Adverse Reactions (6.1)].
Mild to Moderate Alzheimer’s Disease and Mild to Moderate Parkinson’s Disease DementiaThe effective dosage of Rivastigmine Patch is 9.5 mg/24 hours or 13.3 mg/24 hours administered once per day; replace with a new patch every 24 hours.
Interruption of TreatmentIf dosing is interrupted for 3 days or fewer, restart treatment with the same or lower strength Rivastigmine Patch. If dosing is interrupted for more than 3 days, restart treatment with the 4.6 mg/24 hours Rivastigmine Patch and titrate as described above.
2.2 Dosing in Specific PopulationsDosing Modifications in Patients with Hepatic Impairment
Consider using the 4.6 mg/24 hours Rivastigmine Patch as both the initial and maintenance dose in patients with mild (Child-Pugh score 5 to 6) to moderate (Child-Pugh score 7 to 9) hepatic impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Dosing Modifications in Patients with Low Body WeightCarefully titrate and monitor patients with low body weight (<50 kg) for toxicities (e.g., excessive nausea, vomiting) and consider reducing the maintenance dose to the 4.6 mg/24 hours Rivastigmine Patch if such toxicities develop.
2.3 Switching to Rivastigmine Patch from Rivastigmine Capsules or Rivastigmine Oral SolutionPatients treated with rivastigmine capsules or oral solution may be switched to Rivastigmine Patch as follows:
A patient who is on a total daily dose of <6 mg of oral rivastigmine can be switched to the 4.6 mg/24 hours Rivastigmine Patch. A patient who is on a total daily dose of 6 mg to 12 mg of oral rivastigmine can be switched to the 9.5 mg/24 hours Rivastigmine Patch.Instruct patients or caregivers to apply the first patch on the day following the last oral dose.
2.4 Important Administration InstructionsRivastigmine Patch is for transdermal use on intact skin.
(a) Do not use the patch if the pouch seal is broken or the patch is cut, damaged, or changed in any way.
(b) Apply the Rivastigmine Patch once a day
Press down firmly for 30 seconds until the edges stick well when applying to clean, dry, hairless, intact healthy skin in a place that will not be rubbed against by tight clothing. Use the upper or lower back as the site of application because the patch is less likely to be removed by the patient. If sites on the back are not accessible, apply the patch to the upper arm or chest. Do not apply to a skin area where cream, lotion, or powder has recently been applied.(c) Do not apply to skin that is red, irritated, or cut.
(d) Replace the Rivastigmine Patch with a new patch every 24 hours. Instruct patients to only wear one patch at a time (remove the previous day's patch before applying a new patch) [see Warnings and Precautions (5.1) and Overdosage (10)]. If a patch falls off or if a dose is missed, apply a new patch immediately and then replace this patch the following day at the usual application time.
(e) Change the site of patch application daily to minimize potential irritation, although a new patch can be applied to the same general anatomic site (e.g., another spot on the upper back) on consecutive days. Do not apply a new patch to the same location for at least 14 days.
(f) May wear the patch during bathing and in hot weather. But avoid long exposure to external heat sources (excessive sunlight, saunas, solariums).
(g) Place used patches in the previously saved pouch and discard in the trash, away from pets or children.
(h) Wash hands with soap and water after removing the patch. In case of contact with eyes or if the eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve.
2.1 Recommended DosingInitial Dose
Initiate treatment with one 4.6 mg/24 hours Rivastigmine Patch applied to the skin once daily [see Dosage and Administration (2.4)].
Dose TitrationIncrease the dose only after a minimum of 4 weeks at the previous dose, and only if the previous dose has been tolerated. For mild to moderate AD and PDD patients, continue the effective dose of 9.5 mg/24 hours for as long as therapeutic benefit persists. Patients can then be increased to the maximum effective dose of 13.3 mg/24 hours dose. Doses higher than 13.3 mg/24 hours confer no appreciable additional benefit, and are associated with an increase in the incidence of adverse reactions [see Warnings and Precautions (5.2), Adverse Reactions (6.1)].
Mild to Moderate Alzheimer’s Disease and Mild to Moderate Parkinson’s Disease DementiaThe effective dosage of Rivastigmine Patch is 9.5 mg/24 hours or 13.3 mg/24 hours administered once per day; replace with a new patch every 24 hours.
Interruption of TreatmentIf dosing is interrupted for 3 days or fewer, restart treatment with the same or lower strength Rivastigmine Patch. If dosing is interrupted for more than 3 days, restart treatment with the 4.6 mg/24 hours Rivastigmine Patch and titrate as described above.
2.2 Dosing in Specific PopulationsDosing Modifications in Patients with Hepatic Impairment
Consider using the 4.6 mg/24 hours Rivastigmine Patch as both the initial and maintenance dose in patients with mild (Child-Pugh score 5 to 6) to moderate (Child-Pugh score 7 to 9) hepatic impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Dosing Modifications in Patients with Low Body WeightCarefully titrate and monitor patients with low body weight (<50 kg) for toxicities (e.g., excessive nausea, vomiting) and consider reducing the maintenance dose to the 4.6 mg/24 hours Rivastigmine Patch if such toxicities develop.
2.3 Switching to Rivastigmine Patch from Rivastigmine Capsules or Rivastigmine Oral SolutionPatients treated with rivastigmine capsules or oral solution may be switched to Rivastigmine Patch as follows:
A patient who is on a total daily dose of <6 mg of oral rivastigmine can be switched to the 4.6 mg/24 hours Rivastigmine Patch. A patient who is on a total daily dose of 6 mg to 12 mg of oral rivastigmine can be switched to the 9.5 mg/24 hours Rivastigmine Patch.Instruct patients or caregivers to apply the first patch on the day following the last oral dose.
2.4 Important Administration InstructionsRivastigmine Patch is for transdermal use on intact skin.
(a) Do not use the patch if the pouch seal is broken or the patch is cut, damaged, or changed in any way.
(b) Apply the Rivastigmine Patch once a day
Press down firmly for 30 seconds until the edges stick well when applying to clean, dry, hairless, intact healthy skin in a place that will not be rubbed against by tight clothing. Use the upper or lower back as the site of application because the patch is less likely to be removed by the patient. If sites on the back are not accessible, apply the patch to the upper arm or chest. Do not apply to a skin area where cream, lotion, or powder has recently been applied.(c) Do not apply to skin that is red, irritated, or cut.
(d) Replace the Rivastigmine Patch with a new patch every 24 hours. Instruct patients to only wear one patch at a time (remove the previous day's patch before applying a new patch) [see Warnings and Precautions (5.1) and Overdosage (10)]. If a patch falls off or if a dose is missed, apply a new patch immediately and then replace this patch the following day at the usual application time.
(e) Change the site of patch application daily to minimize potential irritation, although a new patch can be applied to the same general anatomic site (e.g., another spot on the upper back) on consecutive days. Do not apply a new patch to the same location for at least 14 days.
(f) May wear the patch during bathing and in hot weather. But avoid long exposure to external heat sources (excessive sunlight, saunas, solariums).
(g) Place used patches in the previously saved pouch and discard in the trash, away from pets or children.
(h) Wash hands with soap and water after removing the patch. In case of contact with eyes or if the eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve.
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Mcneil Consumer Healthcare Div Mcneil-ppc, Inc
Tylenol Cold And Flu Severe | Mcneil Consumer Healthcare Div Mcneil-ppc, Inc
do not take more than directed (see overdose warning) mL = milliliter; TBSP = tablespoon; FL OZ = fluid ounce use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. adults and children 12 years and over take 30 mL (2 TBSP) (1 FL OZ) in the dosing cup provided every 4 hours while symptoms last do not take more than 150 mL (10 TBSP) (5 FL OZ) in 24 hours, unless directed by a doctor children under 12 years ask a doctor
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