RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC (MECLIZINE HCL) TABLET [NUCARE PHARMACEUTICALS, INC.]

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  • RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC (MECLIZINE HCL) TABLET [NUCARE PHARMACEUTICALS, INC.]

RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC (MECLIZINE HCL) TABLET [NUCARE PHARMACEUTICALS, INC.]
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NDC 68071-3063-2, 68071-3063-3, 68071-3063-6, 68071-3063-9
Set ID 4a64c7f3-b304-4e5e-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager NuCare 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 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 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: 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, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium sulfate, stearic acid.

  • 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

    www.rugbylaboratories.com

  • PRINCIPAL DISPLAY PANEL

    pdp

  • INGREDIENTS AND APPEARANCE
    RUGBY  MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC
    meclizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-3063(NDC:0536-1017)
    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
    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)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeCAPSULE (modified capsule shaped uncoated tablet with bisect) Size3mm
    FlavorImprint Code 19G
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-3063-220 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2017
    2NDC:68071-3063-330 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2017
    3NDC:68071-3063-660 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2017
    4NDC:68071-3063-990 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33603/07/2014
    Labeler - NuCare Pharmaceuticals, Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals, Inc.010632300repack(68071-3063)
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