RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]

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  • RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]

RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]
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NDC 71610-245-30, 71610-245-60
Set ID 099d75cc-a2c7-4140-9884-b45010aaf2b5
Category HUMAN OTC DRUG LABEL
Packager Aphena Pharma Solutions - Tennessee, LLC
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

  • Repackaging Information

    Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

    Count25 mg
    3071610-245-30
    9071610-245-60

    Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

    Repackaged by:
    Aphena Pharma Solutions - TN
    Cookeville, TN 38506

    20190314JH

  • PRINCIPAL DISPLAY PANEL - 25 mg

    NDC 71610-245 - Meclizine HCl (Travel Sickness) 25 mg Chewable Tablets
    Bottle Label 25 mg

  • 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:71610-245(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 (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (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:71610-245-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/28/2019
    2NDC:71610-245-6090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/28/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33608/19/2014
    Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(71610-245)
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