Label: BONINE KIDS- chlorcyclizine hydrochloride tablet, chewable

  • 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 June 17, 2009

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  • SPL UNCLASSIFIED SECTION

    ATTENTION: USE ONLY IF TABLET BLISTER SEALS ARE UNBROKEN.

  • QUESTIONS

    Questions? Call 1-800-344-7239
    www.insightpharma.com

  • SPL UNCLASSIFIED SECTION

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

    *DRAMAMINE is a registered trademark of McNEIL-PPC, Inc.

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)     Purpose
    Cyclizine HCl 25 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Antiemetic
  • Uses

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

  • Warnings

    Do not use in children under 6 years of age unless directed by a doctor

    Do not take or give to children if they have a breathing problem such as chronic bronchitis or glaucoma without first consulting a doctor

    Do not take or give to children if they are taking sedatives or tranquilizers without first consulting a doctor

    When using this product

    • do not exceed recommended dosage
    • drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • children 6 years of age and older: chew 1 tablet thoroughly every 6 to 8 hours
    • do not exceed 3 tablets in 24 hours or as directed by a doctor
    • dosage should be taken up to one hour before travel starts or at onset of symptoms
  • Other information

    • store at room temperature 20°–25°C (86°–77°F)
  • Inactive ingredients

    Croscarmellose Sodium, Ethylcellulose, D&C Red #27 Lake, FD&C Blue #2 Lake, Hydroxypropylcellulose, Hypromellose, Magnesium Stearate, Mannitol, N&A Flavors, Sorbitol, Sucralose

  • PRINCIPAL DISPLAY PANEL - Box of 8 Tablets

    CHEWABLE TRAVEL TABLET
    BONINE®

    CYCLIZINE HYDROCHLORIDE • ANTIEMETIC

    FOR KIDS
    The Product to Use at the Onset of Symptoms

    Berry Blast

    8 Chewable Tablets

    PRINCIPAL DISPLAY PANEL - Box of 8 Tablets
  • PRINCIPAL DISPLAY PANEL - Box of 12 Tablets

    BONUS 50% MORE
    12     TABLETS FOR THE PRICE OF 8 TABLETS

    CHEWABLE TRAVEL TABLET
    BONINE®

    CYCLIZINE HYDROCHLORIDE • ANTIEMETIC

    FOR KIDS
    The Product to Use at the Onset of Symptoms

    Berry Blast

    12 Chewable Tablets

    PRINCIPAL DISPLAY PANEL - Box of 12 Tablets
  • INGREDIENTS AND APPEARANCE
    BONINE  KIDS
    chlorcyclizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-044
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Chlorcyclizine Hydrochloride (UNII: NPB7A7874U) (Chlorcyclizine - UNII:M26C4IP44P) Chlorcyclizine25 mg
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    vanilla (UNII: Q74T35078H)  
    Product Characteristics
    ColorPINKScore2 pieces
    ShapeROUNDSize14mm
    FlavorBERRYImprint Code Bonine
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-044-088 in 1 BOX
    2NDC:63736-044-1212 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33606/08/2009
    Labeler - Insight Pharmaceuticals (176792315)
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