RUGBY MECLIZINE HCL 12.5 MG (MECLIZINE HYDROCHLORIDE) TABLET, FILM COATED [RUGBY LABORATORIES]

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  • RUGBY MECLIZINE HCL 12.5 MG (MECLIZINE HYDROCHLORIDE) TABLET, FILM COATED [RUGBY LABORATORIES]

RUGBY MECLIZINE HCL 12.5 MG (MECLIZINE HYDROCHLORIDE) TABLET, FILM COATED [RUGBY LABORATORIES]
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NDC 0536-1178-01, 0536-1178-10
Set ID 6a48ec0c-773d-7f97-e053-2991aa0a0351
Category HUMAN OTC DRUG LABEL
Packager RUGBY LABORATORIES
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 caplet)

    Meclizine HCl, USP 12.5 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 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 a 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: 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

  • STORAGE AND HANDLING

    Other information

    • Each Caplet Contains: Calcium 25 mg
    • Store at room temperature in a dry place
    • Keep lid tightly closed
  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • QUESTIONS

    Questions or comments?

    Call1-800-645-2158

  • 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

    www.rugbylaboratories.com

  • PRINCIPAL DISPLAY PANEL

    Rugby®

    NDC 0536-1178-01

    NEW FORMULA AND APPEARANCE

    Meclizine HCl, USP

    12.5 mg Each

    ANTIEMETIC

    100 CAPLETS

    0536-1178 100-ct

  • INGREDIENTS AND APPEARANCE
    RUGBY MECLIZINE HCL 
    meclizine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1178
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (Film Coated) Score2 pieces
    ShapeCAPSULE (Modified) Size13mm
    FlavorImprint Code 19G
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1178-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/20/201807/31/2022
    2NDC:0536-1178-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/20/201807/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33604/20/201807/31/2022
    Labeler - RUGBY LABORATORIES (079246066)
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