Label: BONINE MAX- meclizine hydrochloride tablet, chewable

  • NDC Code(s): 65197-520-16
  • Packager: WellSpring Pharmaceutical Corporation
  • 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 5, 2022

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  • Active ingredient (in each tablet)

    Meclizine HCl 50 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.

    Ask a doctor before use if you have

    • difficulty in urination due to enlargement of the prostate gland 
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery
    • drowsiness may occur
    • avoid alcoholic drinks

    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

    • do not take more than directed

    • dosage should be taken one hour before travel starts 

    • Chew or crush tablet completely before swallowing; do not swallow tablet whole

    • adults and children 12 years of age and over: take 1 chewable tablet once daily or as directed by a doctor.


  • Other information

    • store at 25°C (77°F); excursions permitted between 15° - 30°C (59° - 86°F)
    • protect from heat and humidity
    • see end flap for expiration date and lot number
  • Inactive ingredients

    corn starch, FD&C red #40 aluminum lake, flavor, lactose anhydrous, magnesium stearate, sodium saccharin, silicon dioxide

  • Questions?

    call toll-free 1 (844) 241-5454 or visit us on the web at www.bonine.com

  • SPL UNCLASSIFIED SECTION

    NDC 65197-520-16

    BONINE MAX STRENGTH 

    Prevents and treats: Dizziness - Nausea - Vomiting - Motion sickness

    ** Results may vary

    ATTENTION:  DO NOT USE IF CARTON IS OPEN OR IF BLISTER IS TORN OR MISSING. Keep carton for important drug facts information.

    MONEY BACK GUARANTEED

    Dist. by: WellSpring Pharmaceutical Corporation
    Sarasota, FL 34243 USA

    © 2023 WellSpring Pharmaceutical Corporation

  • PRINCIPAL DISPLAY PANEL

    NEW!

    9x the Adventure**

    Meclizine HCL - Antiemetic 50 mg

    Prevents and treats: Dizziness - Nausea - Vomiting - Motion sickness

    50 mg MECLIZINE HCL

    Nothing Stronger without a PrescriptionBonine MAX 16 CT Carton

    Bonine MAX

  • INGREDIENTS AND APPEARANCE
    BONINE MAX 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-520
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorPEPPERMINTImprint Code BMX
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65197-520-162 in 1 BOX03/24/2023
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33603/24/2023
    Labeler - WellSpring Pharmaceutical Corporation (110999054)
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