Label: DIMENHYDRINATE tablet

  • NDC Code(s): 0924-1007-01, 0924-1007-02
  • Packager: Acme United Corporation
  • 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 April 26, 2019

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

  • Drug Facts

    Active Ingredient (in each tablet)

    Dimenhydrinate 50 mg

  • PURPOSE

    Purpose

    Antiemetic

  • Uses

    for prevention and treatment of nausea, vomiting or dizziness associated with motion sickness

  • WARNINGS

    Do not use in children under 2 years of age unless directed by a doctor

    Ask doctor before use if you have

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

    Ask doctor or pharmacist before use if you are taking sedatives or tranquilizers.

    When using this product

    • marked drowsiness may occir
    • avoid alcoholic drinks
    • alcohol, sedatives and traquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    If pregnant or breast feeding, ask a helath professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact Poison Control Center (800-222-1222) right away.

  • Directions

    To prevemt motion sickness the first dose should be taken ½ to 1 hour before starting activity.

    To prevent or treat motion sickness:

    Adults and Children (12 years and older)take 1-2 tablets every 4-6 hours, not more than 8 tablets in 24 hours, or as directed by doctor.
    Children 6 to under 12 yearsgive 1 tablet every 6-8 hours, not more than 3 tablets in 24 hours or as directed by doctor.
    Children 2 to under 6 yearsgive ¼ to ½ tablet every 6-8 hours, not more than 1½ tablets in 24 hours or as directed by a doctor

  • Other information

    • each tablet contains calcium 29 mg
    • store at room temperature
    • do not use if packet is open or torn
  • INACTIVE INGREDIENT

    croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose

  • Questions?

    1-800-835-2263

  • SPL UNCLASSIFIED SECTION

    Retain carton for complete product information

    Manufactured for:

    Acme United Corporation

    55 Walls Dr, Fairfield, CT 06824

    www.FirstAidOnly.com

    Made in the USA

    ©2018 Acme United Corporation

  • PRINCIPAL DISPLAY PANEL

    Physician Care®

    Motion Sickness

    Dimenhydrinate/ Antiemetic

    Nausea, Vomiting and Dizziness Relief

    Tamper-Evident Packets of 2 Tablets

    Do not use if packet is open or torn.

    Dimenhydrinate 50mg

    100 Tablets (50 Packets, 2 Tablets each)

    1006-updated-label

  • INGREDIENTS AND APPEARANCE
    DIMENHYDRINATE 
    dimenhydrinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-1007
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMENHYDRINATE (UNII: JB937PER5C) (CHLORTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize9mm
    FlavorImprint Code 1006;1006
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-1007-026 in 1 BAG04/18/2019
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0924-1007-0150 in 1 CARTON04/18/2019
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33604/18/2019
    Labeler - Acme United Corporation (001180207)