Label: MECLINZINE HYDORCHLORIDE- meclinzine hydrochloride - chewable tablet, chewable

  • NDC Code(s): 59961-125-01, 59961-125-02
  • Packager: Bellegrove Medical Supply, Inc.
  • 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 December 13, 2018

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

  • WARNINGS

    Do not use
    • for children under 12 years of age unless unless directed by a physician
    • for frequent or prolonged use except under the advice of a physician

    Ask a doctor before use if you have

    breathing problems such as emphysema, asthma or pulmonary disease
    glaucoma

    if you are 

    • taking sedatives or tranquilizers

    When using this product

    drowsiness may occur
    alcohol, sedatives and tranquilizers may increase the drowsiness effect
    consult with your physician
    avoid alcoholic beverages while taking this product
    use caution when driving a motor vehicle or operating machinery

    Do not exceed recommended dosage

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

    Keep out of reach of children.  In case of overdose, get medical help or contact Poison Control Center right away

    Other information

    • store at room temperature 59-86 degrees F (15-30 degreesC)
    • tamper-evident sealed packets
    • do not use any opened or torn packets
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  • DOSAGE AND ADMINISTAATION

    Directions

    do not use more than directed
    to provent motion sickness, take the first dose one hour before starting activity
    Adults and children (12 years and older)

    1 to 2 tablets once daily or as directed by a Physician

    Do not exceed 2 tablets in 24 hours

    Children under 12 years of age: Do not give to children under 12 years of age

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  • INDICATION AND USAGE

    For the prevention and treatment of the nausea,vomating,or dizziness associated with motion sickness.

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  • OTC-KEEP OUT OF REACH OF CHILDREN

    Do not use
    • for children under 12 years of age unless unless directed by a physician
    Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away

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  • PURPOSE

    When using this product

    drowsiness may occur
    alcohol, sedatives and tranquilizers may increase the drowsiness effect
    consult with your physician
    avoid alcoholic beverages while taking this product
    use caution when driving a motor vehicle or operating machinery

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  • Active ingredients

    anhydrous lactose

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  • Inactive ingredients

    Anhydrous Lactose, Colloidal Silicon Dioxide, Crospovidone, Dextrose, FD&C red #40 aluminum lake, magnesium stearate, Microcrystalline Cellulose, Modified Corn Starch, Propylene Glycol, Raspberry Flavor, Silicon Dioxide, Sodium Saccharin, Stearic Acid, Talc and Vanilla Flavor.

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  • Package label
  • INGREDIENTS AND APPEARANCE
    MECLINZINE HYDORCHLORIDE 
    meclinzine hydrochloride - chewable tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59961-125
    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
    anhydrous lactose (UNII: 3SY5LH9PMK) 1 mg
    Product Characteristics
    Color pink Score no score
    Shape ROUND Size 10mm
    Flavor RASPBERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59961-125-01 2 in 1 PACKAGE 01/01/2012
    1 NDC:59961-125-02 500 in 1 BOX; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 01/01/2012
    Labeler - Bellegrove Medical Supply, Inc. (141647094)
    Registrant - Bellegrove Medical Supply, Inc. (141647094)
    Establishment
    Name Address ID/FEI Business Operations
    Future Pak, Ltd. 087737672 api manufacture(59961-125) , pack(59961-125) , relabel(59961-125)
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