Label: MOTION-TIME CHEWABLE- meclizine hcl tablet, chewable

  • NDC Code(s): 49483-333-01, 49483-333-10, 49483-333-16
  • Packager: Time-Cap Labs, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 17, 2018

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  • 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)
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