Label: PHYSICIANSCARE DIMENHYDRINATE MOTION SICKNESS RELIEF- dimenhydrinate tablet, coated

  • NDC Code(s): 0924-1006-01, 0924-1006-02
  • 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 December 12, 2017

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 treatmeant of nausea, vomiting or dizziness associated with motion sickness

  • Warnings

    Do not use for 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 urinatining 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 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 health professional before use.

    Keep out of the 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 1/2 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 years:give 1 tablet every 6-8 hours, not more than 3 tablets in 24 hours or as directed by a doctor.
    Children 2 to under 6 years:give ¼ to 1/2 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 ingredients

    croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose

  • Questions?

    1-800-835-2263

    www.FirstAidOnly.com

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    Acme United Corporation

    55 Walls Dr, Fairfield, CT 06824

    www.FirstAidOnly.com

    Made in the USA

    2017 Acme United Corporation.

  • Carton Label

    50ct- carton label

  • Packet Label

    pouch 1pouch 2

  • Bag Label

    1006-acme Label

  • INGREDIENTS AND APPEARANCE
    PHYSICIANSCARE DIMENHYDRINATE  MOTION SICKNESS RELIEF
    dimenhydrinate tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-1006
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize9mm
    FlavorImprint Code 1006;1006
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-1006-0150 in 1 CARTON10/05/201303/31/2023
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0924-1006-026 in 1 BAG10/05/201303/31/2023
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33610/05/201303/31/2023
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-1006) , repack(0924-1006)