Label: DRAMAMINE- dimenhydrinate tablet, chewable

  • NDC Code(s): 66715-9809-1
  • Packager: Lil' Drug Store Products, 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 July 19, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Dimenhydrinate 50 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 you have

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

    Ask a doctor or pharmacist before use if you are 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 1/2 to 1 hour before starting activity
    • to prevent or treat motion sickness, see below:
    adults and children 12 years and over
    • take 1 to 2 chewable tablets every 4-6 hours
    • do not take more than 8 chewable tablets in 24 hours, or as directed by a doctor
    children 6 to under 12 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 2 to under 6 years
    • give ½ chewable tablet every 6-8 hours
    • do not give more than 1-½ 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 68°-77°F (20°-25°C)
    • do not use if packet is torn
    • see bottom panel for lot number and expiration date
  • Inactive ingredients

    anhydrous citric acid, aspartame, FD&C yellow 6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol

  • Questions?

    1-800-382-7219

  • SPL UNCLASSIFIED SECTION

    Repackaged and distributed by:
    Lil' Drug Store Products, Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402

  • PRINCIPAL DISPLAY PANEL - 50 mg Tablet Pouch Carton

    #1
    Pharmacist
    Recommended
    Brand

    Dimenhydrinate
    Tablets/Antiemetic

    CHEWABLE FORMULA

    Dramamine®
    MOTION SICKNESS RELIEF

    TREATS SYMPTOMS
    ON THE SPOT

    PREVENTS NAUSEA,
    DIZZINESS & VOMITING

    Convenient
    Chewable Tablets

    2 ORANGE FLAVORED
    TABLETS (50 mg EACH)

    2
    Tablets

    Lil'
    Drug Store®

    Principal Display Panel - 50 mg Tablet Pouch Carton
  • INGREDIENTS AND APPEARANCE
    DRAMAMINE 
    dimenhydrinate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9809
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimenhydrinate (UNII: JB937PER5C) (Chlortheophylline - UNII:GE2UA340FM) Dimenhydrinate50 mg
    Inactive Ingredients
    Ingredient NameStrength
    Anhydrous Citric Acid (UNII: XF417D3PSL)  
    aspartame (UNII: Z0H242BBR1)  
    FD&C yellow no. 6 (UNII: H77VEI93A8)  
    aluminum oxide (UNII: LMI26O6933)  
    magnesium stearate (UNII: 70097M6I30)  
    maltodextrin (UNII: 7CVR7L4A2D)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    ColorORANGEScore2 pieces
    ShapeROUNDSize12mm
    FlavorORANGEImprint Code DRA
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-9809-11 in 1 CARTON08/26/2016
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33605/10/2010
    Labeler - Lil' Drug Store Products, Inc. (093103646)