Label: MECLIZINE HCL 25 MG tablet, chewable

  • 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 January 20, 2020

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  • 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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