DRAMAMINE (DIMENHYDRINATE) TABLET, CHEWABLE [LIL' DRUG STORE PRODUCTS, INC.]

DRAMAMINE (DIMENHYDRINATE) TABLET, CHEWABLE [LIL' DRUG STORE PRODUCTS, INC.]
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NDC 66715-9809-1
Set ID 960a642b-ee7c-4e92-9b5f-930425682dac
Category HUMAN OTC DRUG LABEL
Packager Lil' Drug Store Products, Inc.
Generic Name
Product Class
Product Number
Application Number PART336
  • 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

    Dramamine ®


    motion sickness

    CHEWABLE
    Dual Action:

    Prevents & Relieves Nausea,

    Dizziness and Vomiting


    2

    Orange Flavored

    Tablets (50 mg each)

    Lil'
    Drug Store ®

    PDP

  • 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)

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