Label: MECLIZINE HYDROCHLORIDE 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 September 13, 2022

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

View All Sections
  • DRUG INTERACTIONS

    Active ingredient (in each chewable tablet)
    Meclizine HCl 25 mg

  • PURPOSE

    Purpose

    Antiemetic

  • WHEN USING

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

  • KEEP OUT OF REACH OF CHILDREN

    Do not use in

    children under 12 years of age unless directed by a 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 a doctor or pharmacist before use if

    you are taking sedatives or tranquilizers

    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).

  • WARNINGS

    Do not use in

    children under 12 years of age unless directed by a 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 a doctor or pharmacist before use if

    you are taking sedatives or tranquilizers

    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).

  • INSTRUCTIONS FOR USE

     Dosage should be taken one hour before travel starts

    adults and children 12
    years of age and over chew 1 to 2 tablets once daily, or as directed by a doctor
    children under
    12 years of age do not give this product to children under 12 years of age
    unless directed by a doctor

  • QUESTIONS

     Each tablet contains 0.09 mg of Magnesium and 0.82 mg of Sodium

     store at room temperature in a dry place

     keep lid tightly closed

  • INACTIVE INGREDIENT

    Croscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, French Vanilla Flavor, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid

  • QUESTIONS

    1-800-645-2158

  • SPL UNCLASSIFIED SECTION

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    *This product is not manufactured or distributed by Prestige Brands, Inc owner of the registered trademark Bonine®.

    Distributed by:
    RUGBY® LABORATORIES
    17177 N Laurel Park Dr., Suite 233
    Livonia, MI 48152
    www.rugbylaboratories.com

  • DOSAGE & ADMINISTRATION

  • INDICATIONS & USAGE

  • PURPOSE

  • ACTIVE INGREDIENT

  • PRINCIPAL DISPLAY PANEL

    237196

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72189-196(NDC:0536-1299)
    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
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    RASPBERRY (UNII: 4N14V5R27W)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    VANILLA (UNII: Q74T35078H)  
    Product Characteristics
    ColorpinkScore2 pieces
    ShapeROUNDSize9mm
    FlavorRASPBERRY, VANILLAImprint Code 5172
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72189-196-3030 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2021
    2NDC:72189-196-6060 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33604/12/2021
    Labeler - DIRECT RX (079254320)
    Registrant - DIRECT RX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIRECT RX079254320repack(72189-196)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!