Label: MECLIZINE HYDROCHLORIDE tablet, chewable

  • Category: HUMAN OTC DRUG LABEL

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 July 26, 2023

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  • Drug Facts

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

  • PURPOSE

    Purpose

    Antiemetic

  • Uses

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

  • 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).

  • Directions

     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
  • Other information

     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 or comments?

    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

    Repackaged By: Preferred Pharmaceuticals Inc.

  • PRINCIPAL DISPLAY PANEL

    Rugby

    NDC 68788-7873
    Compare to the active ingredient in Bonine®*

    Meclizibe 25 mg

    Antiemetic

    Chewable Tablets

    Preferred Pharmaceuticals Inc.

    Meclizine HCl 25mg Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7873(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
    CROSPOVIDONE (UNII: 2S7830E561)  
    VANILLA BEAN (UNII: Q74T35078H)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    RASPBERRY (UNII: 4N14V5R27W)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorpink (Rosy) Score2 pieces
    ShapeROUNDSize9mm
    FlavorVANILLA, RASPBERRYImprint Code 5172
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-7873-1100 in 1 BOTTLE; Type 0: Not a Combination Product02/19/2021
    2NDC:68788-7873-31000 in 1 BOTTLE; Type 0: Not a Combination Product02/19/202108/26/2022
    3NDC:68788-7873-230 in 1 BOTTLE; Type 0: Not a Combination Product08/26/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33602/19/2021
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022REPACK(68788-7873)
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