BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]

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BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]
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NDC 65197-275-02, 65197-275-08, 65197-275-12, 65197-275-16, 65197-296-08, 65197-296-16
Set ID ad3d66ca-a52c-43ba-b9e2-6269b8a413a9
Category HUMAN OTC DRUG LABEL
Packager WellSpring Pharmaceutical Corporation
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
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  • 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

    16 ct label

    Bonine 16 ct

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  • Principal Display Panel 65197-296

    8 count carton
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  • 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, 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
    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, UNSPECIFIED FORM (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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