DRAMAMINE FOR KIDS (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]

DRAMAMINE FOR KIDS (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]
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NDC 63029-904-01
Set ID 12bc3f17-ed62-4d0d-9b1e-3835579e711b
Category HUMAN OTC DRUG LABEL
Packager Medtech Products Inc.
Generic Name
Product Class
Product Number
Application Number PART336
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    (in each tablet)

    Dimenhydrinate 25 mg

  • Purpose

    Antiemetic

  • Use

    for prevention and treatment of these symptoms associated with motion sickness:

    • nausea
    • vomiting
    • dizziness
  • Warnings

    Do not use for

    children under 2 years of age unless directed by a doctor

    Ask a doctor before use if the child has

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma

    Ask a doctor or pharmacist before use if the child is

    taking sedatives or tranquilizers

    When using this product

    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    If pregnant or breast-feeding,

    ask a doctor before use.

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • to prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity
    • to prevent or treat motion sickness, see below:
    Children 2
    to under 6

    years
    • give ½ to 1 chewable tablet every 6-8 hours
    • do not give more than 3 chewable tablets
      in 24 hours, or as directed by a doctor
    Children 6
    to under 12

    years
    • give 1 to 2 chewable tablets every 6-8 hours
    • do not give more than 6 chewable tablets in
      24 hours, or as directed by a doctor
  • Other information

    • Phenylketonurics: contains phenylalanine 0.84 mg per tablet
    • store at room temperature 68º - 77ºF (20º - 25ºC)
    • do not use if blister is broken or torn
  • Inactive ingredients

    aspartame, citric acid, flavor, magnesium stearate, methacrylic acid copolymer, sorbitol

  • Questions?

    1-800-382-7219 Dramamine.com

  • PRINCIPAL DISPLAY PANEL

    #1Pharmacist Recommended Brand
    Ages 2 – 12

    Safe, Precise Dose

    Children’s Chewable Formula

    Dramamine MOTION SICKNESS RELIEF for Kids

    8 Chewable Tablets

    Dye Free Grape Flavor

    PRINCIPAL DISPLAY PANEL
#1Pharmacist Recommended Brand
Ages 2 – 12
Safe, Precise Dose
Children’s Chewable Formula
Dramamine MOTION SICKNESS RELIEF for Kids
8 Chewable Tablets
Dye Free Grape Flavor

  • INGREDIENTS AND APPEARANCE
    DRAMAMINE FOR KIDS 
    dimenhydrinate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-904
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize10mm
    FlavorGRAPEImprint Code DRA
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-904-011 in 1 BLISTER PACK
    18 in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33602/15/2012
    Labeler - Medtech Products Inc. (122715688)
    Establishment
    NameAddressID/FEIBusiness Operations
    Contract Pharmacal Corporation057795122MANUFACTURE(63029-904)

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