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Side Effects & Adverse Reactions
for children under 12 years of age unless directed by a doctor.
- glaucoma
- difficulty in urination due to an enlargement of the prostate gland
- a breathing problem such as emphysema or chronic bronchitis
taking sedatives or tranquilizers.
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
for children under 12 years of age unless directed by a doctor.
Ask a doctor before use if you have- glaucoma
- difficulty in urination due to an enlargement of the prostate gland
- a breathing problem such as emphysema or chronic bronchitis
taking sedatives or tranquilizers.
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 prevention and treatment of these symptoms associated with motion sickness:
- nausea
- vomiting
- dizziness
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Motion Sickness Relief Manufacturers
- Greenbrier International, Inc.
- Woonsocket Prescription Center,incorporated
- Harmon Stores
Motion Sickness Relief | Harmon Stores
to prevent motion sickness, the first dose should be taken 1/2 to 1 hour before starting activity adults and children 12 years and over
1 to 2 tablets every 4-6 hours, not to exceed 8 tablets in 24 hours, or as directed by a doctor
children 6 to under 12 years
1/2 to 1 tablet every 6-8 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor
children 2 to under 6 years
1/4 to 1/2 tablet every 6-8 hours, not to exceed 1-1/2 tablets in 24 hours, or as directed by a doctor - Chain Drug Marketing Association Inc
Motion Sickness Relief | Chain Drug Marketing Association Inc
to prevent motion sickness, the first dose should be taken one-half to one hour before starting activity adults and children 12 years of age and over: 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor children 6 to under 12 years of age: 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor children 2 to under 6 years of age: 1/2 tablet every 6-8 hours; not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor - Winco Foods, Llc
Motion Sickness Relief | Winco Foods, Llc
to prevent motion sickness, the first dose should be taken one-half to one hour before starting activity adults and children 12 years of age and over: 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor children 6 to under 12 years of age: 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor children 2 to under 6 years of age: 1/2 tablet every 6-8 hours; not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor - Rite Aid
- Rite Aid
- Target Corporation
- Supervalu Inc.
- L.n.k. International, Inc.
Motion Sickness Relief | Mckesson
If you are under 18 years of age, ask a doctor before use before using this product, read the enclosed self-help guide for complete directions and other information begin using the patch on your quit day if you smoke more than 10 cigarettes per day, use the following schedule below: - Walgreen Co.
Motion Sickness Relief | Laboratoires Clarins
• apply liberally 15 minutes before sun exposure
• apply to all skin exposed to the sun
• children under 6 months: Ask a doctor
• Sun Protection Measures.
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating - Safeway
Motion Sickness Relief | Target Corporation
• if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you. • before using this product, read the enclosed User’s Guide for complete directions and other important information • begin using the lozenge on your quit day • if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule:Weeks 1 to 6
Weeks 7 to 9
Weeks 10 to 12
1 lozenge every
1 to 2 hours
1 lozenge every
2 to 4 hours
1 lozenge every
4 to 8 hours
• nicotine lozenge is a medicine and must be used a certain way to get the best results • place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow lozenge. • you may feel a warm or tingling sensation • occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20-30 minutes) • do not eat or drink 15 minutes before using or while the lozenge is in your mouth • to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks • do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects • do not use more than 5 lozenges in 6 hours . Do not use more than 20 lozenges per day. • it is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider. - Wal-mart Stores Inc
Motion Sickness Relief | Wal-mart Stores Inc
to prevent motion sickness, the first dose should be taken one-half to one hour before starting activity adults and children 12 years of age and over: 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor children 6 to under 12 years of age: 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor - Dolgencorp, Inc. (Dollar General & Rexall)
- Walgreen Co.
- Nash-finch Company
- Amerisourcebergen Drug Corporation (Good Neighbor Pharmacy) 24385
Motion Sickness Relief | Amerisourcebergen Drug Corporation (good Neighbor Pharmacy) 24385
to prevent motion sickness, the first dose should be taken 1/2 to 1 hour before starting activity adults and children 12 years of age and over 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor children 6 to under 12 years 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor children 2 to under 6 years 1/4 to 1/2 tablet every 6-8 hours; not to exceed 1-1/2 tablets in 24 hours, or as directed by a doctor - Western Family Foods, Inc.
Motion Sickness Relief | Western Family Foods, Inc.
to prevent motion sickness, the first dose should be taken 1/2 to 1 hour before starting activity adults and children 12 years and over 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor children 6 to under 12 years 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor children 2 to under 6 years 1/4 to 1/2 tablet every 6-8 hours; not to exceed 1-1/2 tablets in 24 hours, or as directed by a doctor - Woonsocket Prescription Center,incorporated
Motion Sickness Relief | Cangene Biopharma
For intramuscular use only.
2.1 Preparation and HandlingEach vial of VARIZIG contains a minimum potency of 125 IU in 1.2 mL.
Bring VARIZIG to room temperature prior to use.
Inspect VARIZIG for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates.
VARIZIG is for single use only. Discard any unused portion.
Dosing of VARIZIG is based on body weight. Administer a single dose of VARIZIG intramuscularly as recommended in Table 1.
The minimum dose is 62.5 International Units (IU) for small infants under two kilograms body weight; the maximum dose of 625 IU should be administered for all patients greater than 40 kilograms in weight.
Table 1 VARIZIG Dose and Volume of AdministrationWeight of Patient
VARIZIG Dose
Volume to Administer* (milliliters)
Kilograms
Pounds
IU
Number of Vials
≤2.0
≤4.4
62.5
0.5
0.6
2.1–10.0
4.5–22.0
125
1
1.2
10.1–20.0
22.1–44.0
250
2
2.4
20.1–30.0
44.1–66.0
375
3
3.6
30.1–40.0
66.1–88.0
500
4
4.8
≥40.1
≥88.1
625
5
6.0
*Extractable volumes are confirmed using a 21 gauge needle as per USP General Chapters <1> Injections.
Consider a second full dose of VARIZIG for high risk patients who have additional exposures to varicella greater than three weeks after initial VARIZIG administration.
2.2 AdministrationFor intramuscular use only.
Divide the intramuscular dose and administer in two or more injection sites, depending on patient size. Do not exceed 3 milliliters per injection site.
Inject into the deltoid muscle or the anterolateral aspects of the upper thigh. Due to the risk of sciatic nerve injury, do not use the gluteal region as a routine injection site. If the gluteal region is used, only use the upper, outer quadrant.
To prevent the transmission of infectious agents from one person to another, use a new disposable sterile syringe and needle for each individual patient.
- Amerisourcebergen Drug Corporation (Good Neighbor Pharmacy) 24385
Motion Sickness Relief | Amerisourcebergen Drug Corporation (good Neighbor Pharmacy) 24385
to prevent motion sickness, the first dose should be taken 1 hour before starting activity adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor do not exceed 2 tablets in 24 hours - Supervalu Inc.
Motion Sickness Relief | Trigen Laboratories, Llc
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.
The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 12 tablets.
- Rite Aid
Motion Sickness Relief | Teva Pharmaceuticals Usa Inc
2.1 Schizophrenia Adults Dose SelectionOral olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 5 to 10 mg initially, with a target dose of 10 mg/day within several days. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week, since steady state for olanzapine would not be achieved for approximately 1 week in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended.
Efficacy in schizophrenia was demonstrated in a dose range of 10 to 15 mg/day in clinical trials. However, doses above 10 mg/day were not demonstrated to be more efficacious than the 10 mg/day dose. An increase to a dose greater than the target dose of 10 mg/day (i.e., to a dose of 15 mg/day or greater) is recommended only after clinical assessment. Olanzapine is not indicated for use in doses above 20 mg/day.
Dosing in Special PopulationsThe recommended starting dose is 5 mg in patients who are debilitated, who have a predisposition to hypotensive reactions, who otherwise exhibit a combination of factors that may result in slower metabolism of olanzapine (e.g., nonsmoking female patients ≥ 65 years of age), or who may be more pharmacodynamically sensitive to olanzapine [see Warnings and Precautions (5.12), Drug Interactions (7), and Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Maintenance TreatmentThe effectiveness of oral olanzapine, 10 mg/day to 20 mg/day, in maintaining treatment response in schizophrenic patients who had been stable on olanzapine for approximately 8 weeks and were then followed for relapse has been demonstrated in a placebo-controlled trial [see Clinical Studies (14.1)]. The physician who elects to use olanzapine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Adolescents Dose SelectionOral olanzapine should be administered on a once-a-day schedule without regard to meals with a recommended starting dose of 2.5 or 5 mg, with a target dose of 10 mg/day. Efficacy in adolescents with schizophrenia was demonstrated based on a flexible dose range of 2.5 to 20 mg/day in clinical trials, with a mean modal dose of 12.5 mg/day (mean dose of 11.1 mg/day). When dosage adjustments are necessary, dose increments/decrements of 2.5 or 5 mg are recommended.
The safety and effectiveness of doses above 20 mg/day have not been evaluated in clinical trials [see Clinical Studies (14.1)].
Maintenance TreatmentThe efficacy of olanzapine for the maintenance treatment of schizophrenia in the adolescent population has not been systematically evaluated; however, maintenance efficacy can be extrapolated from adult data along with comparisons of olanzapine pharmacokinetic parameters in adult and adolescent patients. Thus, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
2.2 Bipolar I Disorder (Manic or Mixed Episodes) Adults Dose Selection for MonotherapyOral olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 10 or 15 mg. Dosage adjustments, if indicated, should generally occur at intervals of not less than 24 hours, reflecting the procedures in the placebo-controlled trials. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended.
Short-term (3 to 4 weeks) antimanic efficacy was demonstrated in a dose range of 5 mg to 20 mg/day in clinical trials. The safety of doses above 20 mg/day has not been evaluated in clinical trials [see Clinical Studies (14.2)].
Maintenance MonotherapyThe benefit of maintaining bipolar I patients on monotherapy with oral olanzapine at a dose of 5 to 20 mg/day, after achieving a responder status for an average duration of 2 weeks, was demonstrated in a controlled trial [see Clinical Studies (14.2)]. The physician who elects to use olanzapine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Dose Selection for Adjunctive TreatmentWhen administered as adjunctive treatment to lithium or valproate, oral olanzapine dosing should generally begin with 10 mg once-a-day without regard to meals.
Antimanic efficacy was demonstrated in a dose range of 5 mg to 20 mg/day in clinical trials [see Clinical Studies (14.2)]. The safety of doses above 20 mg/day has not been evaluated in clinical trials.
Adolescents Dose SelectionOral olanzapine should be administered on a once-a-day schedule without regard to meals with a recommended starting dose of 2.5 or 5 mg, with a target dose of 10 mg/day. Efficacy in adolescents with bipolar I disorder (manic or mixed episodes) was demonstrated based on a flexible dose range of 2.5 to 20 mg/day in clinical trials, with a mean modal dose of 10.7 mg/day (mean dose of 8.9 mg/day). When dosage adjustments are necessary, dose increments/decrements of 2.5 or 5 mg are recommended.
The safety and effectiveness of doses above 20 mg/day have not been evaluated in clinical trials [see Clinical Studies (14.2)].
Maintenance TreatmentThe efficacy of olanzapine for the maintenance treatment of bipolar I disorder in the adolescent population has not been evaluated; however, maintenance efficacy can be extrapolated from adult data along with comparisons of olanzapine pharmacokinetic parameters in adult and adolescent patients. Thus, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
2.5 Olanzapine and Fluoxetine in Combination: Depressive Episodes Associated with Bipolar I DisorderWhen using olanzapine and fluoxetine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.
AdultsOral olanzapine should be administered in combination with fluoxetine once daily in the evening, without regard to meals, generally beginning with 5 mg of oral olanzapine and 20 mg of fluoxetine. Dosage adjustments, if indicated, can be made according to efficacy and tolerability within dose ranges of oral olanzapine 5 to 12.5 mg and fluoxetine 20 to 50 mg. Antidepressant efficacy was demonstrated with olanzapine and fluoxetine in combination in adult patients with a dose range of olanzapine 6 to 12 mg and fluoxetine 25 to 50 mg. Safety of coadministration of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated in clinical studies.
Children and Adolescents (10 to 17 years of age)Dosage and Administration information for pediatric patients (10 to 17 years) is approved for Eli Lilly and Company’s olanzapine tablets and olanzapine orally disintegrating tablets. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Safety and efficacy of olanzapine and fluoxetine in combination was determined in clinical trials supporting approval of Symbyax (fixed dose combination of olanzapine and fluoxetine). Symbyax is dosed between 3 mg/25 mg (olanzapine/fluoxetine) per day and 12 mg/50 mg (olanzapine/fluoxetine) per day. The following table demonstrates the appropriate individual component doses of olanzapine and fluoxetine versus Symbyax. Dosage adjustments, if indicated, should be made with the individual components according to efficacy and tolerability.
Table 1: Approximate Dose Correspondence Between Symbyax*and the Combination of Olanzapine and Fluoxetine * Symbyax (olanzapine/fluoxetine HCl) is a fixed-dose combination of olanzapine and fluoxetine.For
Use in Combination
Symbyax
(mg/day)
Olanzapine
(mg/day)
Fluoxetine
(mg/day)
3 mg olanzapine/25 mg fluoxetine
6 mg olanzapine/25 mg fluoxetine
12 mg olanzapine/25 mg fluoxetine
6 mg olanzapine/50 mg fluoxetine
12 mg olanzapine/50 mg fluoxetine
2.5
5
10+2.5
5
10+2.5
20
20
20
40+10
40+10
While there is no body of evidence to answer the question of how long a patient treated with olanzapine and fluoxetine in combination should remain on it, it is generally accepted that bipolar I disorder, including the depressive episodes associated with bipolar I disorder, is a chronic illness requiring chronic treatment. The physician should periodically reexamine the need for continued pharmacotherapy.
Olanzapine monotherapy is not indicated for the treatment of depressive episodes associated with bipolar I disorder.
2.7 Olanzapine and Fluoxetine in Combination: Dosing in Special PopulationsThe starting dose of oral olanzapine 2.5 to 5 mg with fluoxetine 20 mg should be used for patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of olanzapine or fluoxetine in combination (female gender, geriatric age, nonsmoking status), or those patients who may be pharmacodynamically sensitive to olanzapine. Dosing modification may be necessary in patients who exhibit a combination of factors that may slow metabolism. When indicated, dose escalation should be performed with caution in these patients. Olanzapine and fluoxetine in combination have not been systematically studied in patients over 65 years of age or in patients under 10 years of age [see Warnings and Precautions (5.12), Drug Interactions (7), and Clinical Pharmacology (12.3)].
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