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 April 20, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Meclizine HCl 25 mg

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  • Purpose

    Antiemetic

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  • Uses

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

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  • 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

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  • 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
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  • Other information

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

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  • Inactive ingredients

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

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  • Questions?

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

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  • 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

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  • PRINCIPAL DISPLAY PANEL 65197-275
  • Principal Display Panel 65197-296
  • INGREDIENTS AND APPEARANCE
    BONINE 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65197-275
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    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
    Color PINK (light pink) Score 2 pieces
    Shape ROUND Size 9mm
    Flavor RASPBERRY, VANILLA Imprint Code Bonine;201
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65197-275-08 1 in 1 BOX 12/15/2014
    1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:65197-275-16 2 in 1 BOX 12/15/2014
    2 8 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3 NDC:65197-275-12 1 in 1 BOX 12/15/2014
    3 12 in 1 BOTTLE; Type 0: Not a Combination Product
    4 NDC:65197-275-02 2 in 1 POUCH; Type 0: Not a Combination Product 12/15/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part336 12/15/2014
    BONINE 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65197-296
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Color PINK Score 2 pieces
    Shape ROUND Size 9mm
    Flavor RASPBERRY Imprint Code Bonine;201
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65197-296-08 1 in 1 BOX 04/19/2017
    1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:65197-296-16 2 in 1 BOX 04/19/2017
    2 8 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part336 04/18/2017
    Labeler - WellSpring Pharmaceutical Corporation (110999054)
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