MOTION-TIME CHEWABLE (MECLIZINE HCL) TABLET, CHEWABLE [TIME-CAP LABS, INC]

MOTION-TIME CHEWABLE (MECLIZINE HCL) TABLET, CHEWABLE [TIME-CAP LABS, INC]
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NDC 49483-333-01, 49483-333-10, 49483-333-16
Set ID 7f3ce1e6-c0d6-4b56-8f7a-6368eb46901f
Category HUMAN OTC DRUG LABEL
Packager Time-Cap Labs, Inc
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Meclizine HCl 25 mg

  • PURPOSE

    Purpose

    Antiemetic

  • INDICATIONS & USAGE

    Uses

    prevents and treats nausea, vomiting, or dizziness associated with motion sickness

  • WARNINGS

    Warnings

    Do not give to children under 12 years of age unless directed by a doctor

  • ASK DOCTOR

    Do not take unless directed by a doctor if you have

    • trouble urinating due to an enlarged prostate gland
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis

  • DO NOT USE

    Do not take if you are

    taking sedatives or tranquilizers, without first consulting your doctor

  • WHEN USING

    When using this product

    • do not exceed recommended dosage
    • drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

    • dosage should be taken one hour before travel starts
    • adults and children 12 years of age and over: take 1 to 2 tablets once daily or as directed by a doctor

  • STORAGE AND HANDLING

    Other information

    • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) in a dry place
    • use by expiration date on package
  • INACTIVE INGREDIENT

    Inactive ingredients

    anhydrous lactose, colloidal silicon dioxide, crospovidone, dextrose, FD-C red 40 aluminum lake, magnesium stearate, microcrystalline cellulose, modified corn starch, propylene glycol, raspberry flavor, silicon dioxide, sodium saccharin, stearic acid, talc, vanilla flavor

  • PRINCIPAL DISPLAY PANEL

    Meclizine HCL Chewable Tablets LABEL COPY

  • INGREDIENTS AND APPEARANCE
    MOTION-TIME  CHEWABLE
    meclizine hcl tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CROSPOVIDONE (UNII: 68401960MK)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    RASPBERRY (UNII: 4N14V5R27W)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    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:49483-333-1616 in 1 BLISTER PACK; Type 0: Not a Combination Product12/17/2018
    2NDC:49483-333-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/17/2018
    3NDC:49483-333-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/17/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33608/09/2010
    Labeler - Time-Cap Labs, Inc (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    Time-Cap Labs, Inc037052099manufacture(49483-333)