Label: RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC)- meclizine hcl tablet, chewable

  • NDC Code(s): 0536-1018-01, 0536-1018-10
  • Packager: RUGBY LABORATORIES
  • 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 January 12, 2017

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredient (in each chewable tablet)

    Meclizine HCl USP 25 mg

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  • PURPOSE

    Purpose

    Antiemetic

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  • INDICATIONS & USAGE

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

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  • 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.

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  • 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

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  • 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

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  • 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.

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  • QUESTIONS

    Questions or comments?

    call 1-800-645-2158

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  • OTHER SAFETY INFORMATION

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

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  • SPL UNCLASSIFIED SECTION

    Distributed by: Rugby Laboratories

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

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  • PRINCIPAL DISPLAY PANEL

    Rugby®

    NDC 0536-1018-01

    Travel Sickness

    Meclizine HCl, USP 25 mg Each

    (ANTIEMETIC)

    100 CHEWABLE TABLETS

    Rugby Meclizine 1018

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  • INGREDIENTS AND APPEARANCE
    RUGBY TRAVEL SICKNESS  MECLIZINE HCL, 25 MG EACH (ANTIEMETIC)
    meclizine hcl tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1018
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color pink Score 2 pieces
    Shape ROUND (Biconvex Uncoated Tablet with Bisect) Size 8mm
    Flavor Imprint Code 21G
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-1018-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/19/2014
    2 NDC:0536-1018-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/19/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 08/19/2014
    Labeler - RUGBY LABORATORIES (079246066)
    Registrant - GEMINI PHARMACEUTICALS INC. (055942270)
    Establishment
    Name Address ID/FEI Business Operations
    GEMINI PHARMACEUTICALS INC. 055942270 manufacture(0536-1018)
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