MOTION-TIME CHEWABLE (MECLIZINE HCL) TABLET, CHEWABLE [BRYANT RANCH PREPACK]

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MOTION-TIME CHEWABLE (MECLIZINE HCL) TABLET, CHEWABLE [BRYANT RANCH PREPACK]
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NDC 71335-0821-0, 71335-0821-1, 71335-0821-2, 71335-0821-3, 71335-0821-4, 71335-0821-5, 71335-0821-6, 71335-0821-7, 71335-0821-8, 71335-0821-9
Set ID 80ce0a14-bcbe-43a9-83a3-5b82366d078a
Category HUMAN OTC DRUG LABEL
Packager Bryant Ranch Prepack
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
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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

  • HOW SUPPLIED

    Product: 71335-0821

    NDC: 71335-0821-0 120 TABLET, CHEWABLE in a BOTTLE

    NDC: 71335-0821-1 30 TABLET, CHEWABLE in a BOTTLE

    NDC: 71335-0821-2 20 TABLET, CHEWABLE in a BOTTLE

    NDC: 71335-0821-3 25 TABLET, CHEWABLE in a BOTTLE

    NDC: 71335-0821-4 40 TABLET, CHEWABLE in a BOTTLE

    NDC: 71335-0821-5 60 TABLET, CHEWABLE in a BOTTLE

    NDC: 71335-0821-6 90 TABLET, CHEWABLE in a BOTTLE

    NDC: 71335-0821-7 8 TABLET, CHEWABLE in a BOTTLE

    NDC: 71335-0821-8 14 TABLET, CHEWABLE in a BOTTLE

    NDC: 71335-0821-9 10 TABLET, CHEWABLE in a BOTTLE

  • Meclizine 25MG Chewable

    Label Image
  • INGREDIENTS AND APPEARANCE
    MOTION-TIME  CHEWABLE
    meclizine hcl tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0821(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 (15 MPA.S AT 5%) (UNII: 68401960MK)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (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:71335-0821-130 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2018
    2NDC:71335-0821-440 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2018
    3NDC:71335-0821-78 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2018
    4NDC:71335-0821-560 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2018
    5NDC:71335-0821-220 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2018
    6NDC:71335-0821-814 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2018
    7NDC:71335-0821-325 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2018
    8NDC:71335-0821-910 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2018
    9NDC:71335-0821-0120 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2018
    10NDC:71335-0821-690 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33608/09/2010
    Labeler - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-0821) , RELABEL(71335-0821)
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