MECLIZINE HYDROCHLORIDE TABLET, CHEWABLE MECLIZINE HCL TABLET, CHEWABLE [DIRECTRX]

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MECLIZINE HYDROCHLORIDE TABLET, CHEWABLE MECLIZINE HCL TABLET, CHEWABLE [DIRECTRX]
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NDC 61919-454-30, 61919-641-20
Set ID 862e048c-eb73-a3b7-e053-2991aa0accf4
Category HUMAN OTC DRUG LABEL
Packager DIRECTRX
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
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  • SPL UNCLASSIFIED SECTION

    Distributed by: Rugby Laboratories

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

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each chewable tablet)

    Meclizine HCl USP 25 mg

  • 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 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.

  • 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

  • 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

  • INACTIVE INGREDIENT


    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.

  • 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

  • KEEP OUT OF REACH OF CHILDREN


    In case of overdose, get medical help or contact a Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    454.30

  • PRINCIPAL DISPLAY PANEL

    641-20

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-454(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)  
    SUCROSE (UNII: C151H8M554)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    Product Characteristics
    ColorpinkScore2 pieces
    ShapeROUND (Biconvex Uncoated Tablet with Bisect) Size8mm
    FlavorImprint Code 21G
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-454-3030 in 1 BOTTLE; Type 0: Not a Combination Product04/10/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33604/10/2019
    MECLIZINE HCL 
    meclizine hcl tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-641(NDC:49483-333)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg  in 25 
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    RASPBERRY (UNII: 4N14V5R27W)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    VANILLA (UNII: Q74T35078H)  
    Product Characteristics
    ColorpinkScore2 pieces
    ShapeROUNDSize9mm
    FlavorRASPBERRYImprint Code TCL333
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-641-2020 in 1 BOTTLE; Type 0: Not a Combination Product04/10/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33604/10/2019
    Labeler - DIRECTRX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIRECTRX079254320repack(61919-454, 61919-641)
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