Label: BONINE- meclizine hydrochloride tablet, chewable

  • NDC Code(s): 65197-275-02, 65197-275-08, 65197-275-12, 65197-275-16, view more
    65197-296-08, 65197-296-16
  • 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 July 26, 2019

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

  • 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 in children under 12 years of age unless directed by a doctor.

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

    When using this product

    • do not exceed recommended dosage
    • you may get drowsy
    • 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 1 (800) 222-1222

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

  • SPL UNCLASSIFIED SECTION

    ATTENTION:  DO NOT USE IF CARTON IS OPEN OR IF BLISTER IS TORN OR MISSING. 

    Dist. by: WellSpring Pharmaceutical Corporation
    Sarasota, FL 34243 USA © WellSpring 2014

  • PRINCIPAL DISPLAY PANEL 65197-275

    16 ct label

    Bonine 16 ct

  • Principal Display Panel 65197-296

    8 count carton
  • INGREDIENTS AND APPEARANCE
    BONINE 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-275
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LACTOSE, UNSPECIFIED FORM (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:65197-275-081 in 1 BOX12/15/2014
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:65197-275-162 in 1 BOX12/15/2014
    28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:65197-275-121 in 1 BOX12/15/2014
    312 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:65197-275-022 in 1 POUCH; Type 0: Not a Combination Product12/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33612/15/2014
    BONINE 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-296
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorPINKScore2 pieces
    ShapeROUNDSize9mm
    FlavorRASPBERRYImprint Code Bonine;201
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65197-296-081 in 1 BOX04/19/2017
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:65197-296-162 in 1 BOX04/19/2017
    28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33604/18/2017
    Labeler - WellSpring Pharmaceutical Corporation (110999054)