Label: MECLIZINE- meclizine hcl 25mg tablet, chewable

  • NDC Code(s): 16103-387-08, 16103-387-11
  • Packager: Pharbest Pharmaceuticals, Inc.
  • 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 8, 2022

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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 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

    • doage should be taken one hour before travel starts  
    Adults and children 12 years and over

    take 1 or 2 tablets once daily or as directed by doctor

  • Other information

    • Tamper Evident: do not use if 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)

  • PRINCIPAL DISPLAY PANEL

    PHARBEST

    NDC 16103-387-11

    Manufactured in the USA

    Chewable, Once-A-Day Protection

    *Compare to the active ingredient in Bonine®

    MECLIZINE

    CHEWABLE

    Raspberry Flavor

    Meclizine HCl 25mg

    Antiemetic

    • Motion Sickness • Nausea • Vomiting

    1000 TABLETS

    Meclizine 25 mg Chewable Tablet Product Label

  • INGREDIENTS AND APPEARANCE
    MECLIZINE 
    meclizine hcl 25mg tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    RASPBERRY (UNII: 4N14V5R27W)  
    Product Characteristics
    Colorpink (LIGHT PINK COLOR) Score2 pieces
    ShapeROUND (ROUND TABLET) Size8mm
    FlavorImprint Code PH051
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16103-387-08100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2018
    2NDC:16103-387-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33602/01/2018
    Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835manufacture(16103-387) , pack(16103-387) , analysis(16103-387) , label(16103-387)
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