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
  • 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 6, 2021

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

  • 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 (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

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

    Dist. by: WellSpring Pharmaceutical Corporation

    Sarasota, FL 34243 USA

    © 2021 WellSpring Pharmaceutical Corporation

    *Less drowsy than Dramamine

    Dramamine is a registered trademark of Prestige Brands, Inc.

  • 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?

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

  • TAMPER EVIDENT 65197-275

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

  • TAMPER EVIDENT 65197-296

    TAMPER EVIDENT: DO NOT USE IF PRINTED TEAR STRIP IS BROKEN OR MISSING. 

  • Dist. by:

     WellSpring Pharmaceutical Corporation

    Sarasota, FL 34243 USA

    © 2021 WellSpring Pharmaceutical Corporation

    *Less drowsy than Dramamine

    Dramamine is a registered trademark of Prestige Brands, Inc.

  • 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

    UP TO 24 HOUR PROTECTION

    BONINE®
    MECLIZINE HYDROCHLORIDE • ANTIEMETIC

    Nausea - Dizziness - Vomiting

    *Less drowsy than Dramamine

    Bonine 12ct LNK

    Bonine 12ct LNK


  • 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 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
    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 BOX08/26/2021
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:65197-296-121 in 1 BOX08/26/2021
    212 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:65197-296-162 in 1 BOX08/26/2021
    38 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33608/26/2021
    Labeler - WellSpring Pharmaceutical Corporation (110999054)