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| Product NDC Code | 49467-124 | ||||||
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| Drug Name | Naus-ease |
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| Type | Brand | ||||||
| Pharm Class | Antiemetic [EPC], Emesis Suppression [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | TABLET | ||||||
| RxCUI drug identifier | 995666, 1372663 |
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| Application Number | ANDA040659 | ||||||
| Labeler Name | Sunascen Therapeutics LLC | ||||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS Anaphylactoid reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision have been reported.
NAUS-EASE Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.Drug Interactions There may be increased CNS depression when Meclizine Hydrochloride, USP is administered concurrently with other CNS depressants, including alcohol, tranquilizers and sedatives. (see WARNINGS ) Based on in vitro evaluation, Meclizine Hydrochloride, USP is metabolized by CYP2D6. Therefore there is a possibility for a drug interaction between Meclizine Hydrochloride, USP and CYP2D6 inhibitors.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Meclizine Hydrochloride, USP is an antihistamine that shows marked protective activity against nebulized histamine and lethal doses of intravenously injected histamine in guinea pigs. It has a marked effect in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. Its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum. Pharmacokinetics The available pharmacokinetic information for Meclizine Hydrochloride, USP following oral administration has been summarized from published literature. Absorption Meclizine Hydrochloride, USP is absorbed after oral administration with maximum plasma concentrations reaching at a median T max value of 3 hours post-dose (range: 1.5 to 6 hours) for the tablet dosage form. Distribution Drug distribution characteristics for Meclizine Hydrochloride, USP in humans remains unknown. Metabolism The metabolic fate of Meclizine Hydrochloride, USP in humans is unknown. In an in vitro metabolic study using human hepatic microsome and recombinant CYP enzyme, CYP 2D6 was found to be the dominant enzyme for metabolism of Meclizine Hydrochloride, USP. The genetic polymorphism of CYP2D6 that results in extensive-, poor-, intermediate- and ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in Meclizine Hydrochloride, USP exposure. Elimination Meclizine Hydrochloride, USP has a plasma elimination half-life of about 5-6 hours in humans.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.Pharmacokinetics The available pharmacokinetic information for Meclizine Hydrochloride, USP following oral administration has been summarized from published literature.
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS Meclizine Hydrochloride, USP 25 mg
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Meclizine Hydrochloride, USP is contraindicated in individuals who have shown a previous hypersensitivity to it.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION Chemically, Meclizine Hydrochloride, USP is 1-( p -Chloro-α-phenylbenzyl)-4-( m -methylbenzyl) piperazine dihydrochloride monohydrate. Meclizine Hydrochloride, USP is an oral antiemetic, which is a white to slightly yellowish crystalline powder having a slight odor and is tasteless. The molecular weight is 481.89 g/mol. It has the following structural formula: C 25 H 27 CIN 2 ·2HCl·H 2 0 M.W. 481.88544 g/mol Meclizine Hydrochloride, USP Structural Formula
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND ADMINISTRATION (DIRECTIONS) Adults and children 12 years of age and over: Take 1 to 2 Naus-Ease® (Meclizine Hydrochloride), USP Tablets (25 mg to 50 mg) by mouth once daily, or as directed by a physician. The initial dose of 25 mg to 50 mg of Naus-Ease® (Meclizine Hydrochloride), USP Tablets should be taken one hour prior to travel for the prevention and treatment of motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, D&C Yellow #10, Aluminum Lake (15-20%).
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE For Consumers (the general public): Naus-Ease® (Meclizine Hydrochloride), USP Tablets are used for the prevention and treatment of nausea and vomiting, or dizziness associated with motion sickness. For Health Professionals: Based on a review of Meclizine Hydrochloride, USP drug by the National Academy of Sciences – National Research Council and/or other information, FDA has classified the indications of Meclizine Hydrochloride, USP as follows: 1. The prevention and treatment (management) of nausea and vomiting, and dizziness associated with motion sickness. 2. For the treatment of vertigo.
Purpose
Information about the drug product’s indications for use.PURPOSE Antiemetic
Spl product data elements
Usually a list of ingredients in a drug product.NAUS-EASE MECLIZINE HYDROCHLORIDE SILICON DIOXIDE CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE D&C YELLOW NO. 10 ALUMINUM OXIDE MECLIZINE HYDROCHLORIDE MECLIZINE TL121
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL Naus-Ease® (Meclizine Hydrochloride), USP; Tablets 25 mg Each Antiemetic – Prevent and Treat: Nausea and Vomiting TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. Naus-Ease® (Meclizine Hydrochloride), USP - Tablet Carton Image
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.OTHER USEFUL INFORMATION Store at controlled room temperature 20-25°C (68-77°F). Protect from heat and humidity. Use by expiration date on package.
QUESTIONS OR COMMENTS? Sunascen Therapeutics LLC PO Box 2773 Wilmington DE 19805 More information is available on the web at www.nausease.com
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN Keep out of reach of children. In case of an overdose, seek medical help or contact a Poison Control Center immediately. Call Poison Control at 1-800-222-1222.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Meclizine Hydrochloride, USP is administered to a nursing woman.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.Pediatric Use Clinical studies establishing safety and effectiveness in children under 12 years of age have not been done; therefore, usage is not recommended in children under 12 years of age unless directed by a doctor.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy Use Pregnancy Category B. Reproduction studies in rats have shown cleft palates at 25 to 50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that Meclizine Hydrochloride, USP increases the risk of abnormalities when administered during pregnancy. Despite the animal findings, it would appear that the possibility of fetal harm is remote. Nevertheless, Meclizine Hydrochloride, USP or any other medication, should be used during pregnancy only if clearly necessary, and after speaking with a health professional.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Naus-Ease® (Meclizine Hydrochloride), USP Tablets are available in 25mg strengths, and is available in 8 and 16 count package sizes. 25 mg tablets; Yellow; Oval shaped; Scored; "TL121" imprinted on each tablet Naus-Ease® (Meclizine Hydrochloride), USP; 8 Tablets: NDC 49467-124-08 Naus-Ease® (Meclizine Hydrochloride), USP; 16 Tablets: NDC 49467-124-16 Distributed by: Sunascen Therapeutics LLC Rockville, MD 20850 USA
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS Pediatric Use Clinical studies establishing safety and effectiveness in children under 12 years of age have not been done; therefore, usage is not recommended in children under 12 years of age unless directed by a doctor. Pregnancy Use Pregnancy Category B. Reproduction studies in rats have shown cleft palates at 25 to 50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that Meclizine Hydrochloride, USP increases the risk of abnormalities when administered during pregnancy. Despite the animal findings, it would appear that the possibility of fetal harm is remote. Nevertheless, Meclizine Hydrochloride, USP or any other medication, should be used during pregnancy only if clearly necessary, and after speaking with a health professional. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Meclizine Hydrochloride, USP is administered to a nursing woman. Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of meclizine has not been evaluated. As Meclizine Hydrochloride, USP undergoes metabolism, hepatic impairment may result in increased systemic exposure of the drug. Treatment with Meclizine Hydrochloride, USP should be administered with caution in patients with hepatic impairment. Renal Impairment The effect of renal impairment on the pharmacokinetics of Meclizine Hydrochloride, USP has not been evaluated. Due to a potential for drug/metabolite accumulation, Meclizine Hydrochloride, USP should be administered with caution in patients with renal impairment and in the elderly as renal function generally declines with age. Drug Interactions There may be increased CNS depression when Meclizine Hydrochloride, USP is administered concurrently with other CNS depressants, including alcohol, tranquilizers and sedatives. (see WARNINGS ) Based on in vitro evaluation, Meclizine Hydrochloride, USP is metabolized by CYP2D6. Therefore there is a possibility for a drug interaction between Meclizine Hydrochloride, USP and CYP2D6 inhibitors.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS Clinical studies establishing safety and effectiveness in children under 12 years of age have not been done; therefore, usage is not recommended in children under 12 years of age unless directed by a doctor. Due to its potential anticholinergic action, do not take unless directed by a doctor if you have a breathing problem such as asthma, emphysema, or chronic bronchitis, glaucoma, or difficulty in urination due to enlargement of the prostate gland. Ask a doctor before use if you are taking sedatives or tranquilizers. When using this product: 1. Do not exceed the recommended dosage. 2. May cause drowsiness. 3. Patients should avoid alcoholic beverages while taking this drug. 4. Since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery. Therefore patients are reminded caution when driving or operating machinery. 5. Alcohol, sedatives and tranquilizers may increase drowsiness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, seek medical help or contact a Poison Control Center right away. Call Poison Control at 1-800-222-1222
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API