RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [PROFICIENT RX LP]

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  • RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [PROFICIENT RX LP]

RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [PROFICIENT RX LP]
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NDC 63187-306-10, 63187-306-15, 63187-306-20, 63187-306-30
Set ID 5c1a89de-6191-4012-8bc2-8bfc42b89cbd
Category HUMAN OTC DRUG LABEL
Packager Proficient Rx LP
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
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  • Active ingredient (in each chewable tablet)

    Meclizine HCl USP 25 mg

  • Purpose

    Antiemetic

  • Uses

    •
    prevents and treats nausea, vomiting or dizziness due to motion sickness
  • Warnings

    Do not use in children under 12 years of age unless directed by a doctor

    Ask a doctor before use if you have

    •
    glaucoma
    •
    a breathing problem such as emphysema or chronic bronchitis
    •
    trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use it you are taking sedatives or tranquilizers.

    When using this product

    •
    may cause drowsiness
    •
    alcohol, sedatives, and tranquilizers may increase drowsiness
    •
    avoid alcoholic drinks
    •
    use caution 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 the poison control center immediately.

  • Directions

    Dosage should be taken one hour before travel starts

    Adults and children 12 years of age and older:

    Chew 1-2 tablets once daily, or as directed by a doctor

    Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor

  • Other information

    •
    Phenylketonurics: Contains Phenylalanine 0.28 mg per tablet
    •
    store at room temperature
  • Inactive ingredients

    aspartame,croscarmellose sodium, dextrose, FD and C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.

  • Questions or comments?

    1-800-645-2158

  • OTHER SAFETY INFORMATION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • Principal Display Panel

    COMPARE TO ACTIVE INGREDIENT IN BONINE®

    Rugby®

    Repackaged by:

    Proficient Rx LP

    Thousand Oaks, CA 91320

    NDC 63187-306-30

    Travel Sickness

    Meclizine HCl, USP 25 mg Each

    (ANTIEMETIC)

    Contains Aspartame

    30 CHEWABLE TABLETS

    63187-306-30
  • INGREDIENTS AND APPEARANCE
    RUGBY TRAVEL SICKNESS  MECLIZINE HCL, 25 MG EACH (ANTIEMETIC)
    meclizine hcl tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-306(NDC:0536-1018)
    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
    ASPARTAME (UNII: Z0H242BBR1)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    SUCROSE (UNII: C151H8M554)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    Product Characteristics
    ColorpinkScore2 pieces
    ShapeROUND (Biconvex Uncoated Tablet with Bisect) Size8mm
    FlavorImprint Code 21G
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-306-1010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2019
    2NDC:63187-306-1515 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2019
    3NDC:63187-306-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2019
    4NDC:63187-306-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33608/19/2014
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(63187-306) , RELABEL(63187-306)
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