Label: BONINE- meclizine hydrochloride tablet, chewable

  • 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 January 11, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Meclizine HCl 25 mg

  • Purpose

    Antiemetic

  • Uses

    prevents and treats nausea, vomiting or dizziness associated with motion sickness

  • Warnings

    Do not use for children under 12 years of age unless directed by a doctor

    Do not take unless directed by a doctor if you have

    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis

    Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor.

    When using this product

    • do not exceed recommended dosage
    • drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery

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

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

  • Directions

    • dosage should be taken one hour before travel starts
    • adults and children 12 years of age and over: take 1 to 2 tablets once daily or as directed by a doctor
  • Other information

    store at room temperature 20°– 25°C (68°–77°F)

  • Inactive ingredients

    Croscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid, Vanilla Flavor.

  • Questions?

    call 1-800-344-7239 or visit us on the web at www.insightpharma.com

  • SPL UNCLASSIFIED SECTION

    Dist. by: INSIGHT Pharmaceuticals Corp.
    Langhorne, PA 19047-1749

  • PRINCIPAL DISPLAY PANEL - 8 Tablet Carton

    BONINE®
    MECLIZINE HYDROCHLORIDE • ANTIEMETIC

    Prevents Motion Sickness

    Chewable
    Once-A-Day
    Protection

    8 Tablets

    PRINCIPAL DISPLAY PANEL - 8 Tablet Carton
  • INGREDIENTS AND APPEARANCE
    BONINE 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-124
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    meclizine hydrochloride (UNII: HDP7W44CIO) (meclizine - UNII:3L5TQ84570) meclizine25 mg
    Inactive Ingredients
    Ingredient NameStrength
    crospovidone (UNII: 68401960MK)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Lactose (UNII: J2B2A4N98G)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    stearic acid (UNII: 4ELV7Z65AP)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Product Characteristics
    ColorPINK (light pink) Score2 pieces
    ShapeROUNDSize9mm
    FlavorRASPBERRY, VANILLAImprint Code Bonine;201
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-124-088 in 1 BOX
    2NDC:63736-124-1212 in 1 BOX
    3NDC:63736-124-1616 in 1 BOX
    4NDC:63736-124-2121 in 1 BOX
    5NDC:63736-124-952 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33606/08/2009
    Labeler - Insight Pharmaceuticals (176792315)
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