RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS INC.]

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  • RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS INC.]

RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS INC.]
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NDC 68788-7262-1, 68788-7262-2, 68788-7262-3, 68788-7262-5
Set ID 79d82db6-4a8e-42e3-8a6e-5c6d0512f436
Category HUMAN OTC DRUG LABEL
Packager Preferred Pharmaceuticals Inc.
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each chewable tablet)

    Meclizine HCl USP 25 mg

  • PURPOSE

    Purpose

    Antiemetic

  • INDICATIONS & USAGE

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

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    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
  • STORAGE AND HANDLING

    Other information

    •
    Phenylketonurics: Contains Phenylalanine 0.28 mg per tablet
    •
    Store at room temperature in a dry place
    •
    Keep lid tightly closed
  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • QUESTIONS

    Questions or comments?

    call 1-800-645-2158

  • OTHER SAFETY INFORMATION

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

  • SPL UNCLASSIFIED SECTION

    Distributed by: Rugby Laboratories

    17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152

    Repackaged By: Preferred Pharmaceuticals Inc.

  • PRINCIPAL DISPLAY PANEL

    Rugby®

    NDC 68788-7262

    Travel Sickness

    Repackaged By: Preferred Pharmaceuticals Inc.

    Meclizine HCl, USP 25 mg Each

    (ANTIEMETIC)

    CHEWABLE TABLETS

    Meclizine HCL 25mg Chewable Tablets
  • 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:68788-7262(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:68788-7262-22 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/24/2018
    2NDC:68788-7262-110 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/24/2018
    3NDC:68788-7262-525 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/24/2018
    4NDC:68788-7262-330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/24/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33609/24/2018
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022REPACK(68788-7262)
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