Label: DRAMAMINE- dimenhydrinate tablet, chewable

  • NDC Code(s): 29485-1216-2, 29485-6925-3, 29485-8048-2
  • Packager: Mechanical Servants, LLC
  • Category: HUMAN OTC DRUG LABEL

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 August 16, 2022

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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:29485-6925
    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:29485-6925-33 in 1 BLISTER PACK02/06/2017
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33602/06/2017
    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 PACK05/10/2010
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33601/01/1994
    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 BOX07/10/2020
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33601/01/1994
    Labeler - Mechanical Servants, LLC (005530951)