Label: RUGBY- rugby tablet

  • 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 March 7, 2014

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 caplet)

    Meclizine HCl, USP 12.5 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 if 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: take 2-4 caplets 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

    Each Caplet Contains: Calcium 25 mg
    store at room temperature in a dry place
    Keep lid tightly closed

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  • INACTIVE INGREDIENT

    Inactive ingredients

    croscarmellose sodium, dicalcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium sulfate, stearic acid.

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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

    www.rugbylaboratories.com

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  • OTC KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE REACH OF CHILDREN

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  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    RUGBY 
    rugby tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67296-1252(NDC:0536-1017)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 12.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    Product Characteristics
    Color white Score 2 pieces
    Shape CAPSULE (modified capsule shaped uncoated tablet with bisect) Size 3mm
    Flavor Imprint Code 19G
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67296-1252-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/07/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 03/07/2014
    Labeler - RedPharm Drug, Inc. (828374897)
    Establishment
    Name Address ID/FEI Business Operations
    RedPharm Drug Inc. 828374897 relabel(67296-1252) , repack(67296-1252)
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