Label: DRAMAMINE- dimenhydrinate tablet, chewable

  • NDC Code(s): 29485-1216-2, 29485-6925-3, 29485-8048-2
  • Packager: Lil' Drug Store Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 5, 2023

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  • DRUG FACTS

    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 1/2 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 1/2 chewable tablet every 6-8 hours

    Do not give more that 1 1/2 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 Dramamine.com

  • SPL UNCLASSIFIED SECTION

    Dist. by Medtech Products Inc., Tarrytown, NY 10591
    A Prestige Consumer Healthcare company. Made in Italy.
    © 2021 Trade dress is owned by Medtech Products Inc.
    All rights reserved.

  • PRINCIPAL DISPLAY PANEL - 50mg Tablet Pouch Blister

    #1
    Pharmacist
    Recommended
    Brand

    Dimenhydrinate
    Tablets/Antiemetic

    Dramamine ®


    motion sickness

    CHEWABLE
    Dual Action:

    Prevents & Relieves Nausea,

    Dizziness and Vomiting


    4

    Orange Flavored

    Tablets (50 mg each)

    PDP

  • PRINCIPAL DISPLAY PANEL - 50mg Tablet Pouch Blister

    #1
    Pharmacist
    Recommended
    Brand

    Dimenhydrinate
    Tablets/Antiemetic

    Dramamine ®


    motion sickness

    CHEWABLE
    Dual Action:

    Prevents & Relieves Nausea,

    Dizziness and Vomiting


    6

    Orange Flavored Tablets (50 mg each)

    DRAMAMINE 6CT

  • PRINCIPAL DISPLAY PANEL - 50mg Tablet Pouch Box

    #1
    Pharmacist
    Recommended
    Brand

    Dimenhydrinate
    Tablets/Antiemetic

    Dramamine ®


    motion sickness

    CHEWABLE
    Dual Action:

    Prevents & Relieves Nausea,

    Dizziness and Vomiting


    25 POUCHES

    2 Orange Flavored Tablets (50 mg each) per Pouch

    PDP

  • INGREDIENTS AND APPEARANCE
    DRAMAMINE 
    dimenhydrinate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-1216
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMENHYDRINATE (UNII: JB937PER5C) (CHLORTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    SORBITOL (UNII: 506T60A25R)  
    ASPARTAME (UNII: Z0H242BBR1)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColororangeScore2 pieces
    ShapeROUNDSize12mm
    FlavorORANGEImprint Code DRA
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-1216-22 in 1 BLISTER PACK05/10/201012/31/2024
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00901/01/199412/31/2024
    DRAMAMINE 
    dimenhydrinate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-6925
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMENHYDRINATE (UNII: JB937PER5C) (CHLORTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    SORBITOL (UNII: 506T60A25R)  
    ASPARTAME (UNII: Z0H242BBR1)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColororangeScore2 pieces
    ShapeROUNDSize12mm
    FlavorORANGEImprint Code DRA
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-6925-33 in 1 BLISTER PACK02/06/201712/31/2024
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00902/06/201712/31/2024
    DRAMAMINE 
    dimenhydrinate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-8048
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMENHYDRINATE (UNII: JB937PER5C) (CHLORTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    SORBITOL (UNII: 506T60A25R)  
    ASPARTAME (UNII: Z0H242BBR1)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColororangeScore2 pieces
    ShapeROUNDSize12mm
    FlavorORANGEImprint Code DRA
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-8048-225 in 1 BOX07/10/202012/31/2025
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00901/01/199412/31/2025
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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