MECLIZINE HCL 25 MG TABLET, CHEWABLE [REDPHARM DRUG, INC.]

MECLIZINE HCL 25 MG TABLET, CHEWABLE [REDPHARM DRUG, INC.]
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NDC 67296-1390-3
Set ID 505f6036-d216-4455-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager RedPharm Drug, Inc.
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
  • ACTIVE INGREDIENT (IN EACH CHEWABLE TABLET)

    Meclizine HCl, USP 25 mg

  • PURPOSE

    Antiemetic

  • USES

    prevents and treats nausea, vomiting or dizziness due to motion sickness

  • WARNINGS

    WARNINGS

  • DO NOT USE

    Do not use in children under 12 years of age unless directed by a doctor.

  • ASK DOCTOR

    Ask a doctor before use if you have

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

  • ASK DOCTOR/PHARMACIST

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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of overdose, get medical help or contact the poison control center immediately.

  • DIRECTIONS

    Dosage should be taken one hour before travel starts.
    Adults and children 12 years of age and older: Chew 1-2 tablets once daily or as directed by a doctor
    Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor.

  • OTHER INFORMATION

    store at room temperature

  • OTHER SAFETY INFORMATION

    Phenylketonurics: Contains phenylalanine 0.28 mg per tablet
    Do not use if imprinted safety seal under cap is broken or missing

  • INACTIVE INGREDIENTS

    aspartame, croscarmellose sodium, dextrose, FD&C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.

  • QUESTIONS OR COMMENTS?

    If you have any questions or comments or to report an adverse event, please contact (800) 795-9775.

  • SPL UNCLASSIFIED SECTION

  • WHEN USING

    When using this product

    may cause drowsiness
    alcohol, sedatives, and tranquilizers may increase drowsiness
    avoid alcoholic drinks
    use caution when driving a motor vehicle or operating machinery

  • PURPOSE

    Antiemetic

  • PRINCIPAL DISPLAY PANEL

    meclizine 25mg

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 25 MG 
    meclizine hcl 25 mg tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67296-1390(NDC:51645-994)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    ASPARTAME (UNII: Z0H242BBR1)  
    SUCROSE (UNII: C151H8M554)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    Product Characteristics
    Colorpink (uncoated) Score2 pieces
    ShapeROUND (bioconvex) Size8mm
    FlavorRASPBERRYImprint Code 21G
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67296-1390-330 in 1 BOTTLE; Type 0: Not a Combination Product10/15/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33610/15/2015
    Labeler - RedPharm Drug, Inc. (828374897)
    Establishment
    NameAddressID/FEIBusiness Operations
    RedPharm Drug, Inc.828374897repack(67296-1390) , relabel(67296-1390)

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