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 February 1, 2018

If you are a consumer or patient please visit this version.

  • 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 for children under 12 years of age unless directed by a doctor.

    Do not take unless directed by a doctor if you have

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

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

    When using this product

    • do not exceed recommended dosage
    • drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • be careful 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.

  • Directions

    • doage should be taken 1 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 room temperature 20°-25°C (68°-77°F)
  • Inactive ingredients

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

  • Questions?

    Adverse drug event call (866) 562-2756 (M - F, 8AM - 4PM EST).

  • PRINCIPAL DISPLAY PANEL

    PHARBEST

    NDC 16103-0387-11

    Manufactured in the USA

    Chewable, Once-A-Day Protection

    MECLIZINE

    CHEWABLE

    Raspberry Flavor

    *Compare to the active ingredient in Bonine®

    Meclizine HCl 25mg

    Anti-Emetic

    • Motion Sickness • Nausea • Vomiting

    1000 TABLETS

    Pharbest Meclizine 25 mg Tablet Package 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)  
    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)