Label: CYCLIVERT - cyclizine hydrochloride tablet

  • NDC Code(s): 16477-401-01
  • Packager: Laser Pharmaceuticals, 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 11/11

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

  • Active Ingredient Section

    Active Ingredient (in each tablet) Cyclizine Hydrochloride 25 mg

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  • Purpose Section

    Purpose  Antiemetic

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  • Keep Out Of Reach Of Children Section

    Keep out of reach of children.

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  • Indications and Uses Section

    Uses  For the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness. For the treatment of vertigo of motion sickness.

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  • Warnings Section

    Warnings

    Do not exceed recommended dosage.

    Ask a doctor or pharmacist before use if you have a breathing problem such as emphysema or chronic bronchitis  glaucoma  difficulty in urination due to enlargement of the prostate gland

    Ask a doctor before use if you are taking sedatives, or tranquilizers.

    Do not give this product to children who have a breathing problem such as chronic bronchitis or who have glaucoma, without first consulting the child's doctor.

    Do not give to children under 6 years of age unless directed by a doctor.

    When using this product you may get drowsy  avoid alcohol drinks  alcohol, sedatives, and tranquilizers may increase the drowsiness effect  be careful when driving a motor vehicle or operating machinery

    In case of overdose, get medical help or contact a Poison Control Center right away.


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  • Pregnancy or Breast Feeding Section

    If pregnant or breast-feeding, ask a health professional before use.

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  • Dosage and Administration

    Directions

    Adults and children 12 years of age and over: 2 tablets every 4-6 hours, not to exceed 8 tablets in 24 hours.

    Children 6 to under 12 years of age: 1 tablet every 6-8 hours, not to exceed 3 tablets in 24 hours.

    Children under 6 years of age: Consult a physician.

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  • Inactive Ingredients Section

    Inactive ingredients  magnesium Stearate, Microcrystalline Cellouse, Sodium Starch Glycolate

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  • Other Information Section

    Other Information

    Store at 59 - 86 degrees F (15 - 30 degrees C)

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  • Questions? Comments? Section

    Questions? Comments?

    Call 1-864-286-8229

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  • Packaging Label Section

    NDC 16477-401-01 Cyclivert Tablets Antiemetic For healthcare Professionals: For the treatment of vertigo of motion sickness.

    Easc tablet contains: Cyclizine HCI .........25 mg  LASER  100 tablets  Rev 9/11  Lot No:   Exp. date:

    Lift Here  For full information, see the product foldout.  Store at 59 - 86 degrees F (15 - 30 degrees C)

    Tamper-evident by foil seal under cap. Do not use if foil seal is broken or missing.

    This bottle is not to be dispensed to the consumer.

    Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

    the labeling for this product includes professional labeling which is not intended for use by the general public.

    WARNING: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

    IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

    LASER   Manufactures for Laser Pharmaceuticals, LLC Greenville, SC 29615


    Cyclivert Label


    Cyclivert Label1

    Cyclivert Label2

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  • INGREDIENTS AND APPEARANCE
    CYCLIVERT 
    cyclizine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:16477-401
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CYCLIZINE HYDROCHLORIDE (CHLORIDE ION) CYCLIZINE HYDROCHLORIDE 25 mg  in 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    Product Characteristics
    Color white (white) Score 2 pieces
    Shape ROUND (Tablet) Size 9mm
    Flavor Imprint Code LAS401
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:16477-401-01 25 mg in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 11/01/2011
    Labeler - Laser Pharmaceuticals, LLC (614417132)
    Registrant - Laser Pharmaceuticals, LLC (614417132)
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