FDA records indicate that there are no current recalls for this drug.
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Flu Relief Therapy Nighttime Severe Cold Recall
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Questions & Answers
Side Effects & Adverse Reactions
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses (12 tablespoons or 180 mL) in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Sore throat warning: 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.
- to make a child sleepy
- 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.
- with any other product containing diphenhydramine, even one used on skin
- with any other product containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
- liver disease
- glaucoma
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- cough accompanied by excessive phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- the blood thinning drug warfarin
- sedatives or tranquilizers
- do not use more than directed (see overdose warning)
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
- redness or swelling is present
- nervousness, dizziness, or sleeplessness occurs
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- cough comes back or occurs with a fever, rash or headache that lasts
These could be signs of a serious condition.
ask a health professional before use.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- to make a child sleepy
- 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.
- with any other product containing diphenhydramine, even one used on skin
- with any other product containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
- liver disease
- glaucoma
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- cough accompanied by excessive phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- the blood thinning drug warfarin
- sedatives or tranquilizers
- redness or swelling is present
- nervousness, dizziness, or sleeplessness occurs
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- cough comes back or occurs with a fever, 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
- temporarily relieves
- minor aches and pains
- sneezing
- headache
- minor sore throat pain
- itchy, watery eyes
- nasal and sinus congestion
- runny nose
- cough due to minor throat and bronchial irritation
- itchy nose or throat
- 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
Flu Relief Therapy Nighttime Severe Cold Manufacturers
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Flu Relief Therapy Nighttime Severe Cold | Apotex Corp.
2.1 General Dosage and AdministrationThe recommended dosage for linezolid formulations for the treatment of infections is described in Table 1.
Table 1. Dosage Guidelines for Linezolid Dosage and Route of Administration Recommended Duration of Treatment (consecutive days) Infection* Pediatric Patients† (Birth through 11 Years of Age) Adults and Adolescents (12 Years and Older) * Due to the designated pathogens [ see Indications and Usage (1)] † Neonates less than 7 days: Most pre-term neonates less than 7 days of age (gestational age less than 34 weeks) have lower systemic linezolid clearance values and larger AUC values than many full-term neonates and older infants. These neonates should be initiated with a dosing regimen of 10 mg/kg every 12 hours. Consideration may be given to the use of 10 mg/kg every 8 hours regimen in neonates with a sub-optimal clinical response. All neonatal patients should receive 10 mg/kg every 8 hours by 7 days of life [ see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)]. ‡ Oral dosing using either linezolid tablets or linezolid for oral suspension [ see How Supplied/Storage and Handling (16)]. Nosocomial pneumonia Community-acquired pneumonia, including concurrent bacteremia 10 mg/kg intravenously or oral‡ every 8 hours 600 mg intravenously or oral‡ every 12 hours 10 to 14 Complicated skin and skin structure infections Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia 10 mg/kg intravenously or oral‡ every 8 hours 600 mg intravenously or oral‡ every 12 hours 14 to 28 Uncomplicated skin and skin structure infections less than 5 yrs: 10 mg/kg oral‡ every 8 hours
5–11 yrs: 10 mg/kg oral‡ every 12 hours Adults: 400 mg oral‡ every 12 hours
Adolescents: 600 mg oral‡ every 12 hours 10 to 14No dose adjustment is necessary when switching from intravenous to oral administration.
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