FDA records indicate that there are no current recalls for this drug.
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Facol Cold And Flu Day Recall
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Side Effects & Adverse Reactions
■ in children under 12 years of age
■ If you ever had an allergic reaction to this product or any of its ingredients.
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist)
■ liver disease
■ asthma, chronic bronchitis or emphysema
■ thyroid disease
■ heart disease
■ diabetes
■ glaucoma
■ high blood pressure
■ taking sedatives or tranquilizers ■ having chicken fox or other infections
■ taking the blood thinning drug warfarin
■ nervousness, dizziness, or sleeplessness, constipation occurs
■ redness or swelling is present ■ fever get worse or lasts more than 3 days
■ new severe symptoms occur ■ pain, cough, nasal congestion gets worse or lasts after 5-6 times of taking a dose.
Liver warnings: This product contains acetaminophen. The maximum dailydose of this product is 10 capsules 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 everyday while using this product
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
Relief mild to moderately severe pain, Temporarily reduce multi cold symptom
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Facol Cold And Flu Day Manufacturers
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Jw Holdings
Facol Cold And Flu Day | Proficient Rx Lp
2.1 Dosing for Adult and Pediatric Patients > 3 Months of AgeExcept for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.
Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children > 3 MonthsbEar/Nose/Throat
Skin/Skin Structure
Genitourinary TractMild/Moderate
500 mg every 12 hours or
250 mg every 8 hours25 mg/kg/day in divided doses
every 12 hours
or
20 mg/kg/day in divided doses
every 8 hoursSevere
875 mg every 12 hours or
500 mg every 8 hours45 mg/kg/day in divided doses
every 12 hours
or
40 mg/kg/day in divided doses
every 8 hoursLower Respiratory Tract
Mild/Moderate or Severe
875 mg every 12 hours or
500 mg every 8 hours45 mg/kg/day in divided doses
every 12 hours
or
40 mg/kg/day in divided doses
every 8 hoursGonorrhea
Acute, uncomplicated ano-genital and urethral infections in males and females3 grams as single oral dose
Prepubertal children:
50 mg/kg amoxicillin, combined with
25 mg/kg probenecid as a single dose.
Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)
b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.
2.3 Dosing for H. pylori InfectionTriple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.
Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.
Please refer to clarithromycin and lansoprazole full prescribing information.
2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral SuspensionTap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.
Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water
Required for ReconstitutionOral Suspension 125 mg/5 mL
80 mL
62 mL
100 mL
78 mL
150 mL
116 mL
Oral Suspension 200 mg/5 mL
50 mL
39 mL
75 mL
57 mL
100 mL
76 mL
Oral Suspension 250 mg/5 mL
80 mL
59 mL
100 mL
74 mL
150 mL
111 mL
Oral Suspension 400 mg/5 mL
50 mL
36 mL
75 mL
54 mL
100 mL
71 mL
After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.
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