BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [INSIGHT PHARMACEUTICALS]

BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [INSIGHT PHARMACEUTICALS]
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NDC 63736-124-08, 63736-124-12, 63736-124-16, 63736-124-21, 63736-124-95
Set ID 0b4b55cd-063e-4d0e-911c-8e03886e15d3
Category HUMAN OTC DRUG LABEL
Packager Insight Pharmaceuticals
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
  • 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 for children under 12 years of age unless directed by a doctor

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

    When using this product

    • do not exceed recommended dosage
    • drowsiness may occur
    • 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.

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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 1-800-344-7239 or visit us on the web at www.insightpharma.com

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  • SPL UNCLASSIFIED SECTION

    Dist. by: INSIGHT Pharmaceuticals Corp.
    Langhorne, PA 19047-1749

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  • PRINCIPAL DISPLAY PANEL - 8 Tablet Carton

    BONINE®
    MECLIZINE HYDROCHLORIDE • ANTIEMETIC

    Prevents Motion Sickness

    Chewable
    Once-A-Day
    Protection

    8 Tablets

    PRINCIPAL DISPLAY PANEL - 8 Tablet Carton
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  • INGREDIENTS AND APPEARANCE
    BONINE 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-124
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    meclizine hydrochloride (UNII: HDP7W44CIO) (meclizine - UNII:3L5TQ84570) meclizine 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    crospovidone (UNII: 68401960MK)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    Aluminum Oxide (UNII: LMI26O6933)  
    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:63736-124-08 8 in 1 BOX
    2 NDC:63736-124-12 12 in 1 BOX
    3 NDC:63736-124-16 16 in 1 BOX
    4 NDC:63736-124-21 21 in 1 BOX
    5 NDC:63736-124-95 2 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 06/08/2009
    Labeler - Insight Pharmaceuticals (176792315)
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