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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

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  • Active Ingredients

    Meclizine HCl  25 mg


    Meclizine Hydrochloride is an oral antiemetic. It is a white to slightly yellow crystalline powder which has a slight odor and is tasteless. Meclizine HCl has the following structural formula:

    Chemical Structure


    C25H27CIN2 - 2HCI - H2O    M.W. 481.89

    The chemical name is 1-(p-chloro-alpha-phenylbenzyl)-4-(m-methyl-benzyl) - piperazine dihydrochloride monohydrate.
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  • Purpose

    Antiemetic
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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 right away. Call Poison Control at 1-800-222-1222.
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  • Indications and Use

    For the prevention and treatment of nausea and vomiting, or dizziness associated with motion sickness
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  • Warnings

    • Not for use in children under 12 years of age unless directed by a doctor.
    • Do not take unless directed by a doctor if you have a breathing problem such as 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. Avoid alcoholic beverages while taking this product
    4. Alcohol, sedatives and tranquilizers may increase drowsiness
    5. Use caution when driving or operating machinery


    • 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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  • Directions

    Adults and children 12 years of age and over: Oral dosage is 1 to 2 film strips (25 to 50mg) once daily, or as directed by a physician. Place 1 to 2 film strips on the tongue to completely dissolve then swallow.

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  • Inactive Ingredients

    • polyethylene oxide
    • hydroxypropyl methylcellulose
    • maltitol
    • acesulfame potassium
    • citric acid
    • sodium citrate
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  • Principal Display Panel

    Meclizine HCl Film Strips, 25 mg Each
    Antiemetic – Prevent and Treat: Nausea and Vomiting

     

    Distributed by: Sunascen Therapeutics LLC
    Rockville, MD 20850 USA

     
    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 expiration date on package


    NAUS-EASE 8 Film Strips: NDC 49467-104-01
    NAUS-EASE 16 Film Strips: NDC 49467-104-16


    Image of Carton Label

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  • INGREDIENTS AND APPEARANCE
    NAUS-EASE 
    meclizine hydrochloride film, soluble
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49467-104
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOLS  
    HYPROMELLOSES  
    MALTITOL  
    ACESULFAME POTASSIUM  
    ANHYDROUS CITRIC ACID  
    ANHYDROUS TRISODIUM CITRATE  
    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
    1 1 in 1 POUCH
    2 NDC:49467-104-16 16 in 1 CARTON
    2 1 in 1 POUCH
    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)
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