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, 65197-296-12, 65197-296-16, 65197-296-24, 65197-296-32
  • Packager: WellSpring Pharmaceutical Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 6, 2021

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  • 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.

  • Directions (65197-275)

    • 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
  • Directions (65197-296)

    • dosage should be taken one hour before travel starts
    • chew or crush tablets completely before swallowing; do not swallow tablets whole
    • adults and children 12 years and over: take 1 to 2 chewable tablets once daily or as directed by a doctor
  • Other information

    TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

    store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • Inactive ingredients (65197-275)

    croscarmellose sodium, crospovidone, FD&C red #40 lake, lactose, magnesium stearate, raspberry flavor, silica, sodium saccharin, stearic acid, vanilla flavor.

  • Inactive Ingredients (65197-296)

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

  • Questions?

    1 (844) 241-5454 or www.bonine.com 

  • TAMPER EVIDENT 65197-275

    TAMPER EVIDENT: DO NOT USE IF TAMPER EVIDENCE TAPE OVER CAP IS BROKEN OR MISSING. 

  • TAMPER EVIDENT 65197-296

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

    Keep Carton for important drug facts information.

  • Dist. by:

    WellSpring Pharmaceutical
    Corporation Sarasota, FL 34243
    ©2023 WellSpring Pharmaceutical Corporation

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 65197-275

    UP TO 24 HOUR PROTECTION

    BONINE®
    MECLIZINE HYDROCHLORIDE • ANTIEMETIC

    Nausea - Dizziness - Vomiting

    *Less drowsy than Dramamine

    Bonine 12 ct

    Bonine 12 ct

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 65197-296

    NEW LOOK! Same great formula

    9X the Adventure**

    **Results may vary.

    Meclizine HCL  •  Antiemetic 25mg

    *Less drowsy than Dramamine ®

    BONINE®

    MECLIZINE HCL

    Prevents & Treats: Motion Sickness / Nausea & Vomiting / Dizziness / Cyber Sickness

    Up to 24 Hours Relief

    Bonine 8ct Blue new Design

    Bonine 8ct Blue new Design

  • 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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    RASPBERRY (UNII: 4N14V5R27W)  
    VANILLA (UNII: Q74T35078H)  
    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:65197-275-121 in 1 BOX12/15/2014
    212 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:65197-275-162 in 1 BOX12/15/2014
    38 in 1 BLISTER PACK; 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 DrugM00912/15/2014
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    RASPBERRY (UNII: 4N14V5R27W)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    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 BOX02/15/2023
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:65197-296-121 in 1 BOX02/15/2023
    212 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:65197-296-162 in 1 BOX02/15/2023
    38 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:65197-296-243 in 1 CARTON05/01/2023
    48 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:65197-296-324 in 1 CARTON06/01/2023
    58 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00902/15/2023
    Labeler - WellSpring Pharmaceutical Corporation (110999054)
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