Label: DRAMAMINE FOR KIDS- dimenhydrinate tablet, chewable

  • 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 April 9, 2020

If you are a consumer or patient please visit this version.

  • 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 dizziness vomiting

  • 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 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 dricing a motor vehicle or opereating 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 Contorl 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 five more than 3 chewable tablets in 24 hours or as directed by a doctor

    Children 6 to 12 years

    • Give 1 to 2 chewable talets 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 0.38 mg per tablet
    • Store at room temperature 20◦-25◦C (68◦-77◦F)
    • Do not use if blister is broken or torn
  • Inactive ingredients

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

  • Questions? 

    1-800-382-7219 Dramamine.com

  • Principal display panel

    Children’s Chewable Formula

    Dramamine ®

    Dimenhydrinate 25 mg/ Antiemetic

    8 Chewable Tablets             Travel case

    Children’s Chewable Formula
Dramamine ®  
Dimenhydrinate 25 mg/ Antiemetic
8 Chewable Tablets		Travel case

  • INGREDIENTS AND APPEARANCE
    DRAMAMINE FOR KIDS 
    dimenhydrinate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-910
    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:63029-910-011 in 1 CASE02/15/2012
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33602/15/2012
    Labeler - Medtech Products Inc. (122715688)