RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [APOTHECA INC.]

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  • RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [APOTHECA INC.]

RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [APOTHECA INC.]
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NDC 12634-246-00, 12634-246-01, 12634-246-71, 12634-246-79, 12634-246-80, 12634-246-85, 12634-246-91, 12634-246-96
Set ID 280dc4d4-7773-3c13-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Apotheca Inc.
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
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  • Active ingredient (in each chewable tablet)

    Meclizine HCl USP 25 mg


  • Purpose

    Antiemetic


  • Uses

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


  • 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


  • Other information


    • Phenylketonurics: Contains Phenylalanine 0.28 mg per tablet
    • store at room temperature
  • Inactive ingredients

    aspartame,croscarmellose sodium, dextrose, FD and C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.


  • Questions or comments?

    1-800-645-2158


  • OTHER SAFETY INFORMATION

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

  • PRINCIPAL DISPLAY PANEL

    label

  • 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:12634-246(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:12634-246-0010 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:12634-246-01100 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:12634-246-7130 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:12634-246-7925 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:12634-246-8020 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:12634-246-8515 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:12634-246-911 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8NDC:12634-246-966 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33608/19/2014
    Labeler - Apotheca Inc. (051457844)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Inc.051457844relabel(12634-246) , repack(12634-246)
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