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Side Effects & Adverse Reactions
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur.
Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.
If pregnant or breast-feeding, ask a doctor before using product.
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Uses
Temporarily relieves these symptoms associated with a cold or flu:
• achiness
• chills
• headache
• fever
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Cold And Flu Manufacturers
- Liddell Laboratories, Inc.
- Hyvee Inc
- Walgreen Company
- Rite Aid
Cold And Flu | Pd-rx Pharmaceuticals, Inc.
2.1 Dosage in Adult Patients with Normal Renal Function
The usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
3 Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
4 Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
5 This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
6 This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
7 Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
8 The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk.
9 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia3
500 mg
7 to 14
Community Acquired Pneumonia4
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 10
Chronic Bacterial Prostatitis
500 mg
28
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)5
750 mg
5
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)6
250 mg
10
Uncomplicated Urinary Tract Infection
250 mg
3
Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg7,8
Pediatric patients < 50 kg and ≥ 6 months of age 7,8
500 mg
see Table 2 below (2.2)
608
608
Plague, adult and pediatric patients > 50 kg9
Pediatric patients < 50 kg and ≥ 6 months of age
500 mg
see Table 2 below (2.2)
10 to 14
10 to 14
2.2 Dosage in Pediatric Patients
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
every Duration2 1 Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
3 Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
4 The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk.
5 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Inhalational Anthrax (post-exposure)3, 4
Pediatric patients > 50 kg
500 mg
24 hr
60 days4
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed
250 mg per dose)
12 hr
60 days4
Plague5
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed
250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal Impairment
Administer levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
Normal Renal
Function Every
24 hours Creatinine
Clearance
20 to 49 mL/min Creatinine
Clearance
10 to 19 mL/min Hemodialysis or
Chronic Ambulatory
Peritoneal Dialysis
(CAPD) 750 mg
750 mg every 48 hours
750 mg initial dose, then
500 mg every 48 hours
750 mg initial dose, then
500 mg every 48 hours
500 mg
500 mg initial dose, then
250 mg every 24 hours
500 mg initial dose, then
250 mg every 48 hours
500 mg initial dose, then
250 mg every 48 hours
250 mg
No dosage adjustment
required
250 mg every 48 hours.
If treating uncomplicated
UTI, then no dosage
adjustment is required
No information on
dosing adjustment is available
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin tablets should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets or the pediatric powder for oral solution [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration Instructions
Food and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1)and Patient Counseling Information (17.2)]. - Walgreen Company
Cold And Flu | Walgreen Company
• take only as directed – see Liver warning • use dose cup • do not exceed 4 doses per 24 hrsadults & children 12 yrs & over
30 mL (2 TBSP) every 6 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
• when using other Daytime or Nighttime products, carefully read each label to insure correct dosing - Hyvee Inc
Cold And Flu | Mylan Institutional Inc.
2.1 AsthmaMontelukast sodium should be taken once daily in the evening. The following doses are recommended:
For adults and adolescents 15 years of age and older: one 10 mg tablet.
For pediatric patients 6 to 14 years of age: one 5 mg chewable tablet.
For pediatric patients 2 to 5 years of age: one 4 mg chewable tablet.
Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.
There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning vs. evening dosing. The pharmacokinetics of montelukast are similar whether dosed in the morning or evening. Efficacy has been demonstrated for asthma when montelukast was administered in the evening without regard to time of food ingestion.
2.2 Exercise-Induced Bronchoconstriction (EIB) in Patients 15 Years of Age and OlderFor prevention of EIB, a single dose of montelukast should be taken at least 2 hours before exercise. The following doses are recommended:
For adults and adolescents 15 years of age and older: one 10 mg tablet.
An additional dose of montelukast should not be taken within 24 hours of a previous dose. Patients already taking montelukast sodium daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB. All patients should have available for rescue a short-acting β-agonist. Safety and efficacy in patients younger than 15 years of age have not been established. Daily administration of montelukast sodium for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.
Pediatric use information for patients ages 6 to 14 years of age for acute prevention of exercise-induced bronchoconstriction (EIB) is approved for Merck Sharp & Dohme Corp’s montelukast tablet products. However, due to Merck Sharp & Dohme Corp’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
2.3 Allergic RhinitisFor allergic rhinitis, montelukast sodium should be taken once daily. Efficacy was demonstrated for seasonal allergic rhinitis when montelukast was administered in the morning or the evening without regard to time of food ingestion. The time of administration may be individualized to suit patient needs.
The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended:
For adults and adolescents 15 years of age and older: one 10 mg tablet.
For pediatric patients 6 to 14 years of age: one 5 mg chewable tablet.
For pediatric patients 2 to 5 years of age: one 4 mg chewable tablet.
Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established.
The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended:
For adults and adolescents 15 years of age and older: one 10 mg tablet.
For pediatric patients 6 to 14 years of age: one 5 mg chewable tablet.
For pediatric patients 2 to 5 years of age: one 4 mg chewable tablet.
Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.
2.4 Asthma and Allergic RhinitisPatients with both asthma and allergic rhinitis should take only one montelukast sodium dose daily in the evening.
- Walgreen Company
- Hyvee Inc
- Hyvee Inc
- Hyvee Inc
Cold And Flu | Hyvee Inc
• take only as directed - see Liver warning • use dose cup • do not exceed 4 doses per 24 hrsadults & children 12 yrs & over
30 mL (2 TBSP) every 6 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
• when using other Daytime or Nighttime products, carefully read each label to insure correct dosing Directions - Daytime • take only as directed - see Liver warning • use dose cup • do not exceed 4 doses per 24 hrsadults & children 12 yrs & over
30 mL (2 TBSP) every 4 hrs
children 6 to under 12 yrs
15 mL (1 TBSP) every 4 hrs
children 4 to under 6 yrs
ask a doctor
children under 4 yrs
do not use
• when using other Daytime or Nighttime products, carefully read each label to insure correct dosing Directions - Daytime • take only as directed - see Liver warning • use dose cup • do not exceed 4 doses per 24 hrsadults & children 12 yrs & over
30 mL (2 TBSP) every 4 hrs
children 6 to under 12 yrs
15 mL (1 TBSP) every 4 hrs
children 4 to under 6 yrs
ask a doctor
children under 4 yrs
do not use
• when using other Daytime or Nighttime products, carefully read each label to insure correct dosing - Hyvee Inc
Cold And Flu | Proficient Rx Lp
Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response.
AdultsFor Edema: The usual adult dosage is 25 to 100 mg daily as a single or divided dose. Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on three to five days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur.
For Control Of Hypertension: The usual initial dose in adults is 25 mg daily given as a single dose. The dose may be increased to 50 mg daily, given as a single or two divided doses. Doses above 50 mg are often associated with marked reductions in serum potassium (see also PRECAUTIONS).
Patients usually do not require doses in excess of 50 mg of hydrochlorothiazide daily when used concomitantly with other antihypertensive agents.
Infants And ChildrenFor Diuresis And For Control Of Hypertension: The usual pediatric dosage is 0.5 to 1 mg per pound (1 to 2 mg/kg) per day in single or two divided doses, not to exceed 37.5 mg per day in infants up to 2 years of age or 100 mg per day in children 2 to 12 years of age. In infants less than 6 months of age, doses up to 1.5 mg per pound (3 mg/kg) per day in two divided doses may be required. (See PRECAUTIONS, Pediatric Use).
- Walgreen Company
Cold And Flu | Walgreen Company
• take only as directed – see Overdose warning • use dose cup • do not exceed 4 doses per 24 hrsadults & children 12 yrs & over
30 mL (2 TBSP) every 6 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
Other information • each 30 mL dose cup contains: sodium 39 mg • store at 20-25°C (68-77°F) - Hyvee Inc
- Hyvee Inc
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