Label: NAUS-EASE- meclizine hydrochloride film, soluble

  • NDC Code(s): 49467-104-01, 49467-104-16
  • Packager: Sunascen Therapeutics LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 14, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    Meclizine Hydrochloride, USP 25 mg

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  • PURPOSE

    Antiemetic

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  • 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

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

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  • 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.

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  • 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.

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  • CONTRAINDICATIONS

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

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  • 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

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  • 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.

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  • 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.

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  • ADVERSE REACTIONS

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

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  • 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.

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  • INACTIVE INGREDIENTS

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

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  • 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 rectanglular 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

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  • QUESTIONS OR COMMENTS?

    Sunascen Therapeutics LLC
    PO Box 2773
    Wilmington DE 19805

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

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  • 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

    Naus-Ease® (Meclizine Hydrochloride), USP - Film Strip Carton Image
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  • INGREDIENTS AND APPEARANCE
    NAUS-EASE 
    meclizine hydrochloride film, soluble
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49467-104
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MALTITOL (UNII: D65DG142WK)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
    Product Characteristics
    Color green Score no score
    Shape RECTANGLE Size 22mm
    Flavor LIME Imprint Code S1
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49467-104-01 8 in 1 CARTON 04/16/2012
    1 1 in 1 POUCH; Type 0: Not a Combination Product
    2 NDC:49467-104-16 16 in 1 CARTON 04/16/2012
    2 1 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 04/16/2012
    Labeler - Sunascen Therapeutics LLC (078272834)
    Registrant - Sunascen Therapeutics LLC (078272834)
    Establishment
    Name Address ID/FEI Business Operations
    Sunascen Therapeutics LLC 078272834 label(49467-104)
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