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  5. Label Information: Naus-ease

FDA Label for Naus-ease

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. DESCRIPTION
    4. CLINICAL PHARMACOLOGY
    5. PHARMACOKINETICS
    6. ABSORPTION
    7. DISTRIBUTION
    8. METABOLISM
    9. ELIMINATION
    10. INDICATIONS AND USAGE
    11. CONTRAINDICATIONS
    12. WARNINGS
    13. PEDIATRIC USE
    14. PREGNANCY USE
    15. NURSING MOTHERS
    16. HEPATIC IMPAIRMENT
    17. RENAL IMPAIRMENT
    18. DRUG INTERACTIONS
    19. KEEP OUT OF REACH OF CHILDREN
    20. ADVERSE REACTIONS
    21. DOSAGE AND ADMINISTRATION (DIRECTIONS)
    22. INACTIVE INGREDIENTS
    23. HOW SUPPLIED
    24. QUESTIONS OR COMMENTS?
    25. PRINCIPAL DISPLAY PANEL

Naus-ease Product Label

The following document was submitted to the FDA by the labeler of this product Sunascen Therapeutics Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



Meclizine Hydrochloride, USP 25 mg


Purpose



Antiemetic


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:

Meclizine Hydrochloride, USP Structural Formula - 2929e3f6 1083 4a5d 8aa6 27c5a093be74

Meclizine Hydrochloride, USP Structural Formula - 2929e3f6 1083 4a5d 8aa6 27c5a093be74

C25H27CIN2·2HCl·H20 M.W. 481.88544 g/mol


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 Tmax 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.


Indications And Usage



For Consumers (the general public):
Naus-Ease® (Meclizine Hydrochloride), USP Film Strips 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.


Contraindications



Meclizine Hydrochloride, USP is contraindicated in individuals who have shown a previous hypersensitivity to it.


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


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.


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.


Adverse Reactions



Anaphylactoid reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision have been reported.


Dosage And Administration (Directions)



Adults and children 12 years of age and over: Take 1 to 2 Naus-Ease® (Meclizine Hydrochloride), USP Film Strips (25 mg to 50 mg) once daily, or as directed by a physician. Place a film strip on the tongue. Allow each film strip to completely dissolve, and then swallow.

The initial dose of 25 mg to 50 mg of Naus-Ease® (Meclizine Hydrochloride), USP Film Strips 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 Ingredients



Polyethylene oxide, Hydroxypropyl methylcellulose, Maltitol, Citric acid, Sodium citrate, and FD&C green #3.


How Supplied



Naus-Ease® (Meclizine Hydrochloride), USP Film Strips are available in 25mg strengths. Each Film Strip is individualy wrapped in a pouch, and is available in 8 and 16 count package sizes.

25 mg (Green rectangular shaped, with "S1" printed on each film strip)

Naus-Ease® (Meclizine Hydrochloride), USP; 8 Film Strips: NDC 49467-104-01
Naus-Ease® (Meclizine Hydrochloride), USP; 16 Film Strips: NDC 49467-104-16

Distributed by:
Sunascen Therapeutics LLC
Rockville, MD 20850 USA


Questions Or Comments?



Sunascen Therapeutics LLC
PO Box 2773
Wilmington DE 19805

More information is available on the web at www.nausease.com


Principal Display Panel



Naus-Ease® (Meclizine Hydrochloride), USP; Film Strips 25 mg Each
Antiemetic – Prevent and Treat: Nausea and Vomiting

TAMPER EVIDENT: EACH FILM STRIP IS INDIVIDUALLY SEALED IN A POUCH. DO NOT USE IF INDIVIDUAL POUCH IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING.

Note:
Store at controlled room temperature 20-30°C. (68-86°F)
Protect from heat and humidity
Use by the expiration date on the package


* Please review the disclaimer below.