DRIMINATE (DIMENHYDRINATE) TABLET [MAJOR PHARMACEUTICALS]

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DRIMINATE (DIMENHYDRINATE) TABLET [MAJOR PHARMACEUTICALS]
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NDC 0904-2051-12, 0904-2051-59
Set ID d2967f78-41ee-4c30-8b47-0757df9f3d91
Category HUMAN OTC DRUG LABEL
Packager Major Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART336
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  • Active ingredient (in each tablet)

    Dimenhydrinate 50 mg

  • Purpose

    Antiemetic

  • Uses

    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
    • difficulty in urination due to enlargement of the prostate gland 

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • marked drowsiness may occur
    • use caution when driving a motor vehicle or operating machinery
    • avoid alcoholic beverages

    If pregnant or breast-feeding,

    ask a health professional before use. 

    Keep out of reach of children.

    In case of 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 one-half to one hour before starting activity
    adults and
    children
    12 years
    and over    		  1 to 2 tablets every 4-6
     hours; do not exceed 8
     tablets in 24 hours, or as
     directed by a doctor
    children 6
    to under
    12 years     		 1/2 to 1 tablet every 6-8
     hours; do not exceed 3
     tablets in 24 hours, or as
     directed by a doctor 
    children 2
    to under
    6 years    		 1/2 tablet every 6-8 hours;
     not to exceed 1 1/2 tablets
     in 24 hours, or as directed
     by a doctor 

  • Other information

    • each tablet contains: calcium 35 mg
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • protect from moisture
    • see end flap for expiration date and lot number
  • Inactive ingredients

    croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid 

  • Questions or comments?

    (800) 616-2471

  • Principal Display Panel

    MAJOR®

    NDC 0904-2051-59

    *Compare to the Active Ingredient in Dramamine® Original Formula

    Driminate™
    Dimenhydrinate USP, Antiemetic

    For Nausea, Dizziness and Vomiting from Motion Sickness

    100 Tablets
    50 mg EACH
    Use as Directed

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    *This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Dramamine® Original Formula.
    50844    REV0518M19812

    Distributed by
    MAJOR® PHARMACEUTICALS
    17177 N Laurel Park Drive, Suite 233
    Livonia, MI 48152 USA       M-17    Rev. 08/18
    Re-order No.  700621

    major 44-198

    major 44-198

  • INGREDIENTS AND APPEARANCE
    DRIMINATE 
    dimenhydrinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-2051
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M, CHLORTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize9mm
    FlavorImprint Code 44;198
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-2051-121 in 1 CARTON12/01/199211/15/2020
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0904-2051-591 in 1 CARTON12/01/1992
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33612/01/1992
    Labeler - Major Pharmaceuticals (191427277)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(0904-2051)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(0904-2051)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(0904-2051)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(0904-2051)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(0904-2051)
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