Label: MECLIZINE- meclizine hcl 25mg tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 26, 2024

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  • Active ingredient (in each tablet)

    Meclizine HCl 25mg

  • Purpose

    Antiemetic

  • Uses

    prevents and treats nausea, vomiting or dizziness associated with motion sickness

  • Warnings

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

  • Do not take this product unless directed by a doctor if you have

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

    Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

    When using this product

    • do not exceed the recommended dosage
    • may cause drowsiness
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • use caution when driving a motor vehicle or operating machinery
  • 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 right away (1 800-222-1222)

  • Directions

    • dosage should be taken one hour before travel starts

    Adults and children 12 years and overtake 1 or 2 tablets once daily or as directed by doctor

  • Other information

    • Tamper Evident: do not use if the safety seal under cap is broken or missing
    • store at 20°-25°C (68°-77°F)
  • Inactive ingredients

    Croscarmellose sodium, dextrose, FD&C Red#40, raspberry flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid

  • Questions or comments?

    (866) 562-2756 (Mon - Fri, 8AM - 4PM EST)

  • Package Label Principal Display Panel

    PHARMAMED

    NDC 84289-387-01

    Manufactured in the USA

    Chewable, Once-A-Day Protection

    MECLIZINE

    Antiemetic

    100 CHEWABLE TABLETS

    Meclizine HCL 25mg

    Raspberry Flavor

    *Compare to the active ingredient in Bonine

    Label Image

  • INGREDIENTS AND APPEARANCE
    MECLIZINE 
    meclizine hcl 25mg tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84289-387(NDC:16103-387)
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    RASPBERRY (UNII: 4N14V5R27W)  
    Product Characteristics
    ColorpinkScore2 pieces
    ShapeROUNDSize8mm
    FlavorRASPBERRYImprint Code PH051
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84289-387-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2024
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)10/01/2024
    Labeler - PHARMAMED USA INC (065607328)
    Registrant - PHARBEST PHARMACEUTICALS, INC. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    PHARBEST PHARMACEUTICALS, INC.557054835repack(84289-387)
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